Clinical trial NCT02496858: Clinical and Genetic Characteristics of Coronary Artery Disease in Chinese Young Adults
Official title: Clinical and Genetic Characteristics of Coronary Artery Disease in Chinese Young Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention
Keywords: Young Patient
Genetic Characteristics
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged ≤45 years diagnosed with CAD by coronary angiography will be collected from multiple institutions.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of cardiac death
timeFrame: 36 months
measure: Number of patients developing myocardial infarction
timeFrame: 36 months
measure: Number of patients developing stroke
timeFrame: 36 months
measure: Number of participants undergoing unscheduled repeat revascularization of target or non-target vessel
timeFrame: 36 months
Secondary outcomes:
measure: Number of stent thrombosis, bleeding、non-cardiac death and all-cause death.
timeFrame: 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital
state: Fujian
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun yat-sen Memorial Hospital
state: Guangdong
city: Zhuhai
country: China
facility: Zhuhai Hospital of Guangdong Provincial People's Hospital
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine
state: Guangxi
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical College
state: Guizhou
city: Shijiazhuang
country: China
facility: The second Hospital of Hebei Medical University
state: Hebei
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Wuxi
country: China
facility: Wuxi Third People's Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Fourth People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Chang chun
country: China
facility: The second Hospital of Jilin University
state: Jilin
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi 'an Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Central Hospital of Jiading District
state: Shanghai
city: Shanghai
country: China
facility: Central Hospital of Minhang District
state: Shanghai
city: Shanghai
country: China
facility: Central Hospital of Yangpu District
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital of Second Military Medical University of Chinese PLA
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai chest hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Shidong Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tongren Hospital
state: Shanghai
city: Shanghai
country: China
facility: Tenth People's Hospital of Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Yueyang hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi cardiovascular hospital
state: Shanxi
city: Taiyuan
country: China
facility: Taiyuan central hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Karamay
country: China
facility: Karamay Central Hospital
state: Xinjiang
city: Kunming
country: China
facility: Yan'an Hospital of Kunming City
state: Yunnan
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhenjiang First People's Hospital
state: Zhenjiang
Study officials:
References: