• Title/Summary/Keyword: Prospective registry

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Clinical Research of Korean Medicine and Western Medicine Collaboration Registry for Low Back Pain: A Pilot Study Protocol (요통에 대한 협진 레지스트리 임상연구: 예비 임상연구 프로토콜)

  • Kim, Byung-Jun;Shin, Byung-Cheul;Heo, In;Lim, Kyeong-Tae;Park, In Hwa;Hwang, Eui-Hyoung
    • Journal of Korean Medicine Rehabilitation
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    • v.27 no.3
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    • pp.117-124
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    • 2017
  • Objectives Collaboration medicine means cooperate with western medicine and traditional korean medicine to treat the one disease. In Korea, Interest in collaboration medicine is increasing, But the number of studies is scare. Therefore we will conduct collaboration medicine study for the low back pain. Methods This study composes prospective cohort registry study. If the patients who need collaboration medicine by doctor come, we will ask regist this study. And patient select collaboration treatment group and single treatment group. Total 120 patients will recruit from collaboration pilot project hospitals. Each group patient will observed 4 weeks. Telephone research will conducted after 1 month from the last follow up. During the treatment, patients are treated usual treatment type of each medicine. Primary outcome is NRS and secondary outcomes are EQ-5D and ODI. We will analyze difference of 1 week and 4 week outcome result. Conclusions This study is the first large sample size study effect of collaboration medicine in Korea for low back pain. We check present collaboration system and improve collaboration system. Aim of this study is to find the effectiveness collaboration medicine for low back pain in the real condition. And we expect this pilot study will provide the clinical collaboration information and basis.

Establishment and Perspective of the Korean ALS Registry (한국 근위축성측삭경화증 등록체계의 구축과 향후 전망)

  • Sohn, Eun-Hee;Kim, Byung-Jo;Kim, Jong-Kuk;Bae, Jong-Seok;Baek, Won-Ki;Suh, Bum-Chun;Sung, Jung-Joon;Ahn, Suk-Won;Cho, Joong-Yang;Hong, Yoon-Ho;The Korean ALS/MND Research Group, The Korean ALS/MND Research Group
    • Annals of Clinical Neurophysiology
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    • v.13 no.2
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    • pp.71-79
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    • 2011
  • Geographical differences in the incidence of amyotrophic lateral sclerosis (ALS) have been reported, and there are still many unresolved problems. The incidence as well as epidemiologic data of ALS is not known in Korea. Web-based multicenter registry of ALS, the Korean ALS registry, was established at January, 2011. The aim of "the Korean ALS registry" is the following: (1) to establish a database for the prospective collection of epidemiological information; (2) to assess the incidence and prevalence; (3) to find the temporal and geographic trends in the disease; (4) to define the full clinical spectrum of the disease; (5) to develop treatment guideline based on the database.

The Third Nationwide Korean Heart Failure III Registry (KorHF III): The Study Design Paper

  • Minjae Yoon;Eung Ju Kim;Seong Woo Han;Seong-Mi Park;In-Cheol Kim;Myeong-Chan Cho;Hyo-Suk Ahn;Mi-Seung Shin;Seok Jae Hwang;Jin-Ok Jeong;Dong Heon Yang;Jae-Joong Kim;Jin Oh Choi;Hyun-Jai Cho;Byung-Su Yoo;Seok-Min Kang;Dong-Ju Choi
    • International Journal of Heart Failure
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    • v.6 no.2
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    • pp.70-75
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    • 2024
  • With advancements in both pharmacologic and non-pharmacologic treatments, significant changes have occurred in heart failure (HF) management. The previous Korean HF registries, namely the Korea Heart Failure Registry (KorHF-registry) and Korean Acute Heart Failure Registry (KorAHF-registry), no longer accurately reflect contemporary acute heart failure (AHF) patients. Our objective is to assess contemporary AHF patients through a nationwide registry encompassing various aspects, such as clinical characteristics, management approaches, hospital course, and long-term outcomes of individuals hospitalized for AHF in Korea. This prospective observational multicenter cohort study (KorHF III) is organized by the Korean Society of Heart Failure. We aim to prospectively enroll 7,000 or more patients hospitalized for AHF at 47 tertiary hospitals in Korea starting from March 2018. Eligible patients exhibit signs and symptoms of HF and demonstrate either lung congestion or objective evidence of structural or functional cardiac abnormalities in echocardiography, or isolated right-sided HF. Patients will be followed up for up to 5 years after enrollment in the registry to evaluate long-term clinical outcomes. KorHF III represents the nationwide AHF registry that will elucidate the clinical characteristics, management strategies, and outcomes of contemporary AHF patients in Korea.

A Prospective Study on an Association between Apolipoprotein E ${\varepsilon}4$ and Cognitive Change in Community-Dwelling Elders with Alzheimer's Disease (일 지역 알츠하이머병 노인에서 Apolipoprotein E ${\varepsilon}4$와 인지변화의 연관에 대한 전향적 연구)

  • Kang, Min Sung;Moon, Seok Woo
    • Korean Journal of Biological Psychiatry
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    • v.20 no.3
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    • pp.104-110
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    • 2013
  • Objectives : The aim of this study was to examine the prospective impact of the apolipoprotein E (APOE) ${\varepsilon}4$ on cognitive performance in the community-dwelling elderly individuals with Alzheimer's disease (AD). Methods : The total number of subjects was 30 (12 men and 18 women) who were diagnosed with AD from a Korean project of "Early Detection of Dementia". People aged 65-85 years were included in the analysis. The eight neuropsychological domains from the Korean version of Consortium to Establish a Registry of Alzheimer's Disease (CERAD-K) were conducted to test subjects. They have been followed at 24-month intervals with the same assessments at each interval. Their cognitive performance at 2 year intervals was compared by the occurrence of the APOE ${\varepsilon}4$. Results : The impact of ${\varepsilon}4$ allele was significant in the Word List Memory Test (WLMT, F = 4.345, df = 1, p = 0.021) and Word List Recall Test (WLRT, F = 5.569, df = 1, p = 0.033). Conclusions : The APOE ${\varepsilon}4$ allele was significantly correlated especially with verbal episodic memory domain in community-dwelling elders diagnosed with AD.

Rationale, Design, and Interim Observations of the Steady Movement With Innovating Leadership for Heart Failure (SMILE HF) Registry: A Multicenter Prospective Cohort Registry for Patients With Acute Heart Failure

  • Jah Yeon Choi;Mi-Na Kim;Seongwoo Han;Sunki Lee;Myung Soo Park;Min Gyu Kong;Sung-Hea Kim;Yong-Hyun Kim;Sang-Ho Jo;Sungeun Kim;Seonghoon Choi;Jinsung Jeon;Jieun Lee;Byambakhand Battumur;Seong-Mi Park;Eung Ju Kim;SMILE HF Investigators
    • International Journal of Heart Failure
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    • v.6 no.3
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    • pp.129-136
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    • 2024
  • Background and Objectives: Heart failure (HF) is a leading cause of hospitalization and death worldwide. The Steady Movement with Innovating Leadership for Heart Failure (SMILE HF) aims to evaluate the clinical characteristics, management, hospital course, and long-term outcomes of patients hospitalized for acute HF in South Korea. Methods: This prospective, observational multicenter cohort study was conducted on consecutive patients hospitalized for acute HF in nine university hospitals since September 2019. Enrolment of 2000 patients should be completed in 2024, and follow-up is planned through 2025. Results: Interim analysis of 1,052 consecutive patients was performed to understand the baseline characteristics. The mean age was 69±15 years; 57.6% were male. The mean left ventricular ejection fraction was 39±15%. The prevalences of HF with reduced ejection fraction, HF with mildly reduced ejection fraction, and HF with preserved ejection fraction were 50.9%, 15.3%, and 29.2%. Ischemic cardiomyopathy (CMP) was the most common etiology (32%), followed by tachycardia-induced CMP (12.8%) and idiopathic dilated CMP (9.5%). The prescription rate of angiotensin-converting enzyme inhibitor/angiotensin receptor blockers/angiotensin receptor/neprilysin inhibitor, beta-blockers, spironolactone, and sodium-glucose cotransporter-2 inhibitors at discharge were 76.8%, 66.5%, 50.0%, and 17.5%, respectively. The post-discharge 90-day mortality and readmission rates due to HF aggravation were 2.0% and 6.4%, respectively. Our analysis reveals the current state of acute HF in South Korea. Conclusions: Our interim analysis provides valuable insights into the clinical characteristics, management, and early outcomes of acute HF patients in South Korea, highlighting the current state and treatment patterns in this population.

Efficacy and Safety of Sirolimus-Eluting Stent With Biodegradable Polymer UltimasterTM in Unselected Korean Population: A Multicenter, Prospective, Observational Study From Korean Multicenter Ultimaster Registry

  • Soohyung Park;Seung-Woon Rha;Byoung Geol Choi;Jae-Bin Seo;Ik Jun Choi;Sung-Il Woo;Soo-Han Kim;Tae Hoon Ahn;Jae Sang Kim;Ae-Young Her;Ji-Hun Ahn;Han Cheol Lee;Jaewoong Choi;Jin Soo Byon;Markz RMP Sinurat;Se Yeon Choi;Jinah Cha;Su Jin Hyun;Cheol Ung Choi;Chang Gyu Park
    • Korean Circulation Journal
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    • v.54 no.6
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    • pp.339-350
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    • 2024
  • Background and Objectives: UltimasterTM, a third-generation sirolimus-eluting stent using biodegradable polymer, has been introduced to overcome long term adverse vascular events, such as restenosis or stent thrombosis. In the present study, we aimed to evaluate the 12-month clinical outcomes of UltimasterTM stents in Korean patients with coronary artery disease. Methods: This study is a multicenter, prospective, observational registry across 12 hospitals. To reflect real-world clinical evidence, non-selective subtypes of patients and lesions were included in this study. The study end point was target lesion failure (TLF) (the composite of cardiac death, target vessel myocardial infarction [MI], and target lesion revascularization [TLR]) at 12-month clinical follow up. Results: A total of 576 patients were enrolled between November 2016 and May 2021. Most of the patients were male (76.5%), with a mean age of 66.0±11.2 years. Among the included patients, 40.1% had diabetes mellitus (DM) and 67.9% had acute coronary syndrome (ACS). At 12 months, the incidence of TLF was 4.1%. The incidence of cardiac death was 1.5%, MI was 1.0%, TLR was 2.7%, and stent thrombosis was 0.6%. In subgroup analysis based on the presence of ACS, DM, hypertension, dyslipidemia, or bifurcation, there were no major differences in the incidence of the primary endpoint. Conclusions: The present registry shows that UltimasterTM stent is safe and effective for routine real-world clinical practice in non-selective Korean patients, having a low rate of adverse events at least up to 12 months.

Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry

  • Joongmin Kim;Young-Guk Ko;Seung-Jun Lee;Chul-Min Ahn;Seung-Woon Rha;Cheol Ung Choi;Pil-Ki Min;Jong Kwan Park;Ji-Yong Jang;Young Jin Youn;Tae-Soo Kang;Chang-Hwan Yoon;Donghoon Choi
    • Korean Circulation Journal
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    • v.54 no.9
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    • pp.565-576
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    • 2024
  • Background and Objectives: The K-ELUVIA study aimed to investigate the clinical effectiveness and safety of EluviaTM, a polymer-coated, paclitaxel-eluting stent, for femoropopliteal artery disease using data from a prospective Korean multicenter registry. Methods: A total of 105 patients with femoropopliteal artery disease who received endovascular treatment (EVT) with EluviaTM stents at 7 Korean sites were enrolled in a prospective cohort and followed for 2 years. The primary endpoint was the 2-year clinical patency. The secondary endpoint was 2-year freedom from clinically driven target lesion revascularization (TLR). Results: Mean patient age was 68.2±10.4 years, and most patients (82.7%) were male. Mean lesion length was 168.3±117.6 mm. Chronic total occlusion was found in 57.7% of patients. Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) type C or D lesions were present in 46.1% of patients. Procedural success was achieved in 99.0% of patients. The clinical patency rate was 84.4% at 1 year after EVT and 76.3% at 2 years post-EVT. The freedom from TLR rate was 89.1% at 1 year after EVT and 79.1% at 2 years post-EVT. Chronic total occlusion (hazard ratio [HR], 3.53; 95% confidence interval [CI], 1.08-11.67; p=0.039) and smaller mean stent diameter (HR, 0.40; 95% CI, 0.16-0.98; p=0.044) were identified as independent predictors of loss of clinical patency at 2 years. Conclusions: The K-ELUVIA study demonstrated favorable 2-year clinical effectiveness and safety outcomes of Eluvia stent for femoropopliteal artery lesions in real-world practice.

Cryoballoon Catheter Ablation in Korean Patients With Paroxysmal and Persistent Atrial Fibrillation: One Year Outcome From the Cryo Global Registry

  • Hong Euy Lim;Il-Young Oh;Fred J Kueffer;Kelly Anna van Bragt;Young Keun On
    • Korean Circulation Journal
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    • v.52 no.10
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    • pp.755-767
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    • 2022
  • Background and Objectives: Cryoballoon catheter ablation for the treatment of patients with symptomatic atrial fibrillation (AF) has been adopted globally, but there are limited multicenter reports of 12-month outcomes in the Korean patient population. This analysis evaluated the clinical performance and safety of cryoballoon ablation (CBA) according to standard-of-care practices in Korea. Methods: This evaluation of Korean patients with AF was conducted within the larger Cryo Global Registry, which is a prospective, multicenter, post-market registry. Freedom from a ≥30-second recurrence of atrial arrhythmias (after a 90-day blanking period until 12 months) and procedural safety were examined in subjects treated with CBA at 3 Korean centers. Results: Overall, 299 patients with AF (60±11 years old, 24.7% female, 50.5% paroxysmal AF) underwent CBA using the Arctic Front Advance cryoballoon. Of those, 298 were followed-up for at least 12 months. Mean procedure-, left atrial dwell- and fluoroscopy time was 76±21 minutes, 56±23 minutes, and 27±23 minutes, respectively. Freedom from AF recurrence at 12 months was 83.9% (95% confidence interval [CI], 76.9-88.9%) in the paroxysmal and 61.6% (95% CI, 53.1-69.0%) in the persistent AF cohort. Rhythm monitoring was performed on average 4.7±1.4 times during the follow-up period. Serious device- or procedure-related adverse events occurred in 2 patients (0.7%). The 12-month Kaplan-Meier estimate of freedom from repeat ablation and cardiovascular-related hospitalization was 93.8% (95% CI, 90.4-96.1%) and 89.7% (95% CI, 85.6-92.7%), respectively. Conclusions: CBA is an efficient, effective, and safe procedure for the treatment of AF patients when used according to real-world practices in Korea.

Sex differences in clinical characteristics and long-term outcome in patients with heart failure: data from the KorAHF registry

  • Hyue Mee Kim;Hack-Lyoung Kim;Myung-A Kim;Hae-Young Lee;Jin Joo Park;Dong-Ju Choi
    • The Korean journal of internal medicine
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    • v.39 no.1
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    • pp.95-109
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    • 2024
  • Background/Aims: Sex differences in the prognosis of heart failure (HF) have yielded inconsistent results, and data from Asian populations are even rare. This study aimed to investigate sex differences in clinical characteristics and long-term prognosis among Korean patients with HF. Methods: A total of 5,625 Korean patients hospitalized for acute HF were analyzed using a prospective multi-center registry database. Baseline clinical characteristics and long-term outcomes including HF readmission and death were compared between sexes. Results: Women were older than men and had worse symptoms with higher N-terminal pro B-type natriuretic peptide levels. Women had a significantly higher proportion of HF with preserved ejection fraction (HFpEF). There were no significant differences in in-hospital mortality and rate of guideline-directed medical therapies in men and women. During median follow-up of 3.4 years, cardiovascular death (adjusted hazard ratio [HR], 1.38; 95% confidence interval [CI], 1.07-1.78; p = 0.014), and composite outcomes of death and HF readmission (adjusted HR, 1.13; 95% CI, 1.01-1.27; p = 0.030) were significantly higher in men than women. When evaluating heart failure with reduced ejection fraction (HFrEF) and HFpEF separately, men were an independent risk factor of cardiovascular death in patients with HFrEF. Clinical outcome was not different between sexes in HFpEF. Conclusions: In the Korean multi-center registry, despite having better clinical characteristics, men exhibited a higher risk of all-cause mortality and readmission for HF. The main cause of these disparities was the higher cardiovascular mortality rate observed in men compared to women with HFrEF.

Pilot Study on Characterization of Patients with Low Back Pain: Multi-center, Prospective, Observation Study (요통 환자의 특성 조사 예비 연구: 다기관, 전향적, 관찰연구)

  • Park, Chang-Hyun;Jang, Bo-Hyoung;Ko, You-Me;Park, Dong-Su;Kim, Soon-Joong;Park, Won-Hyung;Cha, Yun-Yeop;Ko, Seong-Gyu;Song, Yun-Kyung
    • Journal of Korean Medicine Rehabilitation
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    • v.26 no.2
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    • pp.123-132
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    • 2016
  • Objectives The aim of this study done as pilot study is to analyze the current state of patients who have low back pain through registry. Methods This study is done under approval of Gil Oriental Medical Hospital of Gachon University, Oriental Medical Hospital of Sangji University, Jecheon Oriental Medical Hospital of Se-Myung University IRB. Among subjects who signed the consent form by their own will, we decided whom to register as subjects of this study by the standard of selection and exception. We collected the sociological investigation, character of low pack pain, degree of symptom which they felt before and after the hospitalization from registered subjects. Results 1. The number of the subjects is 16. The average age is 41.0. 9 of them are female, 7 of them are male. Most of the subjects have history illness which has connection with low pack pain. 2. According to the patient's free description of the back pain, 6 of them suffered throbbing pain. And 8 of the patients have chronic pain, 6 of them have intermittent pain of back pain analysing the character of the low back pain. They answered the pain lasted for 47.6 minutes on average. 3. About the change on the average R.O.M. of L-spine, R.O.M. of Lateral bending, Extension, Flexion, Rotation has increased after leaving the hospital compared with before hospitalization. 4. The amount of discomfort or strength of pain, which was checked by VAS on the day of leaving the hospital, has decreased than they were before the hospitalization. And there was the improvement on the dysfunction score and EQ-5D. Conclusions Through this study, we specifically analyzed the symptoms of the low back pain by accumulating the analysis about the symptoms using several indicators and description which is freely spoken by patients about their symptoms. Further research is expected to complete multi-center registry by building registry and by using it, to get various epidemiologic informations about low back pain.