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NCT02496858 Clinical Trial

Clinical and Genetic Characteristics of Coronary Artery Disease in Chinese Young Adults

Coronary Artery Disease Clinical Trial

— GRAND  

Official title:
Clinical and Genetic Characteristics of Coronary Artery Disease in Chinese Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02496858
Other study ID # ZS-CV-2015
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 12, 2017
Est. completion date May 2022

Study information
Verified date February 2019
Source Shanghai Zhongshan Hospital
Contact Kang Yao, M.D., Ph.D.
Phone 86+13818988550
Email yao.kang@zs-hospital.sh.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to identify genetic loci,or gene variations contributing to the development of coronary artery disease (CAD) in Chinese young adults. Investigators will compare coronary angiogram results to genetic findings within young CAD patients.

Description:

During last 10 years, the rise in coronary artery disease (CAD) prevalence in Chinese young adults is observed and percutaneous coronary intervention (PCI) is generally considered to be low operative risk in these young patients. Genome-wide association studies have identified a considerable number of common genetic variants related to CAD. However, the extent to which these genetic variants are related to the future cardiovascular events, the prevalence, extent, severity, and prognosis of young patients with CAD is not clear.

The aim of this study is to investigate the genetic loci, or gene variations contributing to the development and prognosis of CAD in Chinese young adult. Investigators will compare the angiogram results to genetic findings first in patients with different stages of CAD. Then, investigators will collect patients from hospital discharge registry, and compare long-term outcome as well as on operative details in different gene groups.

The results of the study provide a possibility to develop a gene test to recognize patients at risk at its early stage, and needing for preventive medicine.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date May 2022
Est. primary completion date May 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion criteria:

1. premature CAD, includes patients who aged = 18 and = 45 years , and with at least one main coronary artery stenosis = 50% confirmed by coronary angiography, involving left main coronary artery, left anterior descending branch, left circumflex branch or right coronary artery, and manifested as occult CAD, stable CAD, unstable angina pectoris, non-ST segment elevated myocardial infarction and ST segment elevated myocardial infarction;

2. mature CAD, refers to patients who aged = 65 years and meat the same CAD diagnostic criteria as above;

3. age matched individuals who had coronary arteries without obvious stenosis.

Exclusion criteria:

1. severely sick with limited life-expectancy < 1 year;

2. patients with malignancies;

3. pregnant or planning for pregnancy.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China China-Japan Friendship Hospital Beijing Beijing
China The second Hospital of Jilin University Chang chun Jilin
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Sun yat-sen Memorial Hospital Guangzhou Guangdong
China Second Affiliated Hospital of Zhejiang University Hangzhou Zhejiang
China Zhenjiang First People's Hospital Hangzhou Zhenjiang
China Karamay Central Hospital Karamay Xinjiang
China Yan'an Hospital of Kunming City Kunming Yunnan
China The First Hospital of Lanzhou University Lanzhou Gansu
China The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine Nanning Guangxi
China Central Hospital of Jiading District Shanghai Shanghai
China Central Hospital of Minhang District Shanghai Shanghai
China Central Hospital of Yangpu District Shanghai Shanghai
China Changhai Hospital of Second Military Medical University of Chinese PLA Shanghai Shanghai
China Shanghai Changzheng Hospital Shanghai Shanghai
China Shanghai chest hospital Shanghai Shanghai
China Shanghai First People's Hospital Shanghai Shanghai
China Shanghai Ninth People's Hospital Shanghai Shanghai
China Shanghai Shidong Hospital Shanghai Shanghai
China Shanghai Sixth People's Hospital Shanghai Shanghai
China Shanghai Tongren Hospital Shanghai Shanghai
China Shanghai Zhongshan Hospital Shanghai Shanghai
China Tenth People's Hospital of Tongji University Shanghai Shanghai
China Tongji Hospital of Tongji University Shanghai Shanghai
China Yueyang hospital Shanghai Shanghai
China The second Hospital of Hebei Medical University Shijiazhuang Hebei
China Shanxi cardiovascular hospital Taiyuan Shanxi
China Taiyuan central hospital Taiyuan Shanxi
China Tianjin Chest Hospital Tianjin Tianjin
China Wuhan Asia Heart Hospital Wuhan Hubei
China Wuxi Third People's Hospital Wuxi Jiangsu
China The First Affiliated Hospital of Xi 'an Jiaotong University Xi'an Shaanxi
China Xiamen Cardiovascular Hospital Xiamen Fujian
China Xuzhou Fourth People's Hospital Xuzhou Jiangsu
China General Hospital of Ningxia Medical University Yinchuan Ningxia
China Zhuhai Hospital of Guangdong Provincial People's Hospital Zhuhai Guangdong
China Affiliated Hospital of Zunyi Medical College Zunyi Guizhou

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of cardiac death Any death from cardiac conditions 36 months
Primary Number of patients developing myocardial infarction Any case of acute myocardial infarction which meet the Criteria according to current guidelines. 36 months
Primary Number of patients developing stroke Any events of ishcemic stroke, TIA or hemorrhagic stroke 36 months
Primary Number of participants undergoing unscheduled repeat revascularization of target or non-target vessel Any unshceduled percutaneous coronary intervention or coronary artery bypass grafting after primary revascularization 36 months
Secondary Number of stent thrombosis, bleeding?non-cardiac death and all-cause death. Composite of stent thrombosis, bleeding?non-cardiac death and all-cause death. 36 months
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