NCT02496858

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

38 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
1.8 years until next milestone

Study Start

First participant enrolled

May 12, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

July 7, 2015

Last Update Submit

February 20, 2019

Conditions

Keywords

Young PatientGenetic Characteristics

Outcome Measures

Primary Outcomes (4)

  • Number of cardiac death

    Any death from cardiac conditions

    36 months

  • Number of patients developing myocardial infarction

    Any case of acute myocardial infarction which meet the Criteria according to current guidelines.

    36 months

  • Number of patients developing stroke

    Any events of ishcemic stroke, TIA or hemorrhagic stroke

    36 months

  • 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 Outcomes (1)

  • Number of stent thrombosis, bleeding、non-cardiac death and all-cause death.

    36 months

Study Arms (3)

Early-onset CAD

The anticipated 2000 young CAD patients who aged ≤45years undergoing coronary angiography will be recruited in the prospective cohort. Medical history and risk-factor information were obtained by interviewing patients and by abstracting information from medical records.

Late-onset CAD

The anticipated 2000 old CAD patients aged≥65years undergoing coronary angiography will be recruited in the prospective cohort. Medical history and risk-factor information were obtained by interviewing patients and by abstracting information from medical records.

Age-matched controls

The anticipated 2000 control subjects without obvious coronary stenosis aged≤45years or ≥65years will be recruited in the prospective cohort. Medical history and risk-factor information were obtained by interviewing patients and by abstracting information from medical records.

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients aged ≤45 years diagnosed with CAD by coronary angiography will be collected from multiple institutions.

You may qualify if:

  • 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;
  • mature CAD, refers to patients who aged ≥ 65 years and meat the same CAD diagnostic criteria as above;
  • age matched individuals who had coronary arteries without obvious stenosis.

You may not qualify if:

  • severely sick with limited life-expectancy \< 1 year;
  • patients with malignancies;
  • pregnant or planning for pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

Xiamen Cardiovascular Hospital

Xiamen, Fujian, China

RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Sun yat-sen Memorial Hospital

Guangzhou, Guangdong, China

RECRUITING

Zhuhai Hospital of Guangdong Provincial People's Hospital

Zhuhai, Guangdong, China

RECRUITING

The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine

Nanning, Guangxi, China

RECRUITING

Affiliated Hospital of Zunyi Medical College

Zunyi, Guizhou, China

RECRUITING

The second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

RECRUITING

Wuxi Third People's Hospital

Wuxi, Jiangsu, China

RECRUITING

Xuzhou Fourth People's Hospital

Xuzhou, Jiangsu, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

The second Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

RECRUITING

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China

RECRUITING

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Hospital of Jiading District

Shanghai, Shanghai Municipality, China

RECRUITING

Central Hospital of Minhang District

Shanghai, Shanghai Municipality, China

RECRUITING

Central Hospital of Yangpu District

Shanghai, Shanghai Municipality, China

RECRUITING

Changhai Hospital of Second Military Medical University of Chinese PLA

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai chest hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Shidong Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Tongren Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Tenth People's Hospital of Tongji University

Shanghai, Shanghai Municipality, China

RECRUITING

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, China

RECRUITING

Yueyang hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanxi cardiovascular hospital

Taiyuan, Shanxi, China

RECRUITING

Taiyuan central hospital

Taiyuan, Shanxi, China

RECRUITING

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Karamay Central Hospital

Karamay, Xinjiang, China

RECRUITING

Yan'an Hospital of Kunming City

Kunming, Yunnan, China

ACTIVE NOT RECRUITING

Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Zhenjiang First People's Hospital

Hangzhou, Zhenjiang, China

RECRUITING

Related Publications (1)

  • Wu R, Su Y, Liao J, Shen J, Ma Y, Gao W, Dong Z, Dai Y, Yao K, Ge J. Exome Sequencing Identified Susceptible Genes for High Residual Risks in Early-Onset Coronary Atherosclerotic Disease. Clin Cardiol. 2024 Dec;47(12):e70066. doi: 10.1002/clc.70066.

Biospecimen

Retention: SAMPLES WITH DNA

2 samples of EDTA blood (2ml glass) and 1 sample of serum (2ml glass) will be retained in a biobank.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Kang Yao, M.D., Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 7, 2015

First Posted

July 14, 2015

Study Start

May 12, 2017

Primary Completion

May 1, 2019

Study Completion

May 1, 2022

Last Updated

February 21, 2019

Record last verified: 2019-02

Locations