Coronary Artery DiseaseGRANDNCT02496858
Clinical and Genetic Characteristics of Coronary Artery Disease in Chinese Young Adults
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Shanghai Zhongshan Hospital at 38 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention
- How many people
- 2,000 participants
- Where
- 38 sitesChina
- Study dates
- 12 May 2017to May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients aged ≤45 years diagnosed with CAD by coronary angiography will be collected from multiple institutions.
Who may be able to join
- 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.
Who cannot join
- severely sick with limited life-expectancy < 1 year;
- patients with malignancies;
- pregnant or planning for pregnancy.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
China38 sites, 37 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Jingang Zheng
- Recruiting
The second Hospital of Jilin University
Changchun, Jilin
Bin Liu
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Yingling Zhou
- Recruiting
Sun yat-sen Memorial Hospital
Guangzhou, Guangdong
Jingfeng Wang
- Recruiting
Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
Jianan Wang
- Recruiting
Zhenjiang First People's Hospital
Hangzhou, Zhenjiang
Guohui Zhang
- Recruiting
Karamay Central Hospital
Karamay, Xinjiang
Xiaohong Liu
- Active, not recruiting
Yan'an Hospital of Kunming City
Kunming, Yunnan
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu
Zheng Zhang
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Zeqi Zheng
- Recruiting
The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine
Nanning, Guangxi
Guixin He
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Kang Yao, 86-13818988550
Yuxiang Dai
- Recruiting
Central Hospital of Jiading District
Shanghai, Shanghai Municipality
Xiangdong Xu
- Recruiting
Central Hospital of Minhang District
Shanghai, Shanghai Municipality
Wei Hu
- Recruiting
Central Hospital of Yangpu District
Shanghai, Shanghai Municipality
Pengxiang Zheng
- Recruiting
Changhai Hospital of Second Military Medical University of Chinese PLA
Shanghai, Shanghai Municipality
Xianxian Zhao
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
Chun Liang
- Recruiting
Shanghai chest hospital
Shanghai, Shanghai Municipality
Ben He
- Recruiting
Shanghai First People's Hospital
Shanghai, Shanghai Municipality
Shaowen Liu
- Recruiting
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality
Junfeng Zhang
- Recruiting
Shanghai Shidong Hospital
Shanghai, Shanghai Municipality
Liuliu Feng
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality
Chengxing Shen
- Recruiting
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality
Zening Shen
- Recruiting
Tenth People's Hospital of Tongji University
Shanghai, Shanghai Municipality
Yawei Xu
- Recruiting
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality
Xuebo Liu
- Recruiting
Yueyang hospital
Shanghai, Shanghai Municipality
Min Fan
- Recruiting
The second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Yongjun Li
- Recruiting
Shanxi cardiovascular hospital
Taiyuan, Shanxi
Xuebin Han
- Recruiting
Taiyuan central hospital
Taiyuan, Shanxi
Dengfeng Ma
- Recruiting
Tianjin Chest Hospital
Tianjin, Tianjin Municipality
Yin Liu
- Recruiting
Wuhan Asia Heart Hospital
Wuhan, Hubei
Xi Su
- Recruiting
Wuxi Third People's Hospital
Wuxi, Jiangsu
Xiaoyan Wang
- Recruiting
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi
Yanni Wang
- Recruiting
Xiamen Cardiovascular Hospital
Xiamen, Fujian
Yan Wang
- Recruiting
Xuzhou Fourth People's Hospital
Xuzhou, Jiangsu
Yijie Huang
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Shaobin Jia
- Recruiting
Zhuhai Hospital of Guangdong Provincial People's Hospital
Zhuhai, Guangdong
Yingling Zhou
- Recruiting
Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou
Bei Shi
About this study
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.
Read the 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.
- Keywords
- Young Patient, Genetic Characteristics
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cardiac death
Any death from cardiac conditions
Measured: 36 months
Number of patients developing myocardial infarction
Any case of acute myocardial infarction which meet the Criteria according to current guidelines.
Measured: 36 months
Number of patients developing stroke
Any events of ishcemic stroke, TIA or hemorrhagic stroke
Measured: 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
Measured: 36 months
Secondary outcomes (1)
Number of stent thrombosis, bleeding、non-cardiac death and all-cause death.
Composite of stent thrombosis, bleeding、non-cardiac death and all-cause death.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study start12 May 2017
- Primary completionMay 2019 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junbo Ge, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496858
- Sponsor's protocol ID
- ZS-CV-2015
- Acronym
- GRAND
- Status last verified
- Feb 2019
- First submitted
- 7 Jul 2015
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39673281
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Genetic Characteristics of Coronary Artery Disease in Chinese Young Adults
- ClinicalTrials.gov ID
- NCT02496858
- Acronym / sponsor ID
- GRAND / ZS-CV-2015
- Keywords
- Young Patient, Genetic Characteristics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients aged ≤45 years diagnosed with CAD by coronary angiography will be collected from multiple institutions.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- severely sick with limited life-expectancy < 1 year;
- patients with malignancies;
- pregnant or planning for pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of cardiac death
Time frame: 36 months
Any death from cardiac conditions
Number of patients developing myocardial infarction
Time frame: 36 months
Any case of acute myocardial infarction which meet the Criteria according to current guidelines.
Number of patients developing stroke
Time frame: 36 months
Any events of ishcemic stroke, TIA or hemorrhagic stroke
Number of participants undergoing unscheduled repeat revascularization of target or non-target vessel
Time frame: 36 months
Any unshceduled percutaneous coronary intervention or coronary artery bypass grafting after primary revascularization
1 secondary outcome
Number of stent thrombosis, bleeding、non-cardiac death and all-cause death.
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Derived from this study: PubMed 39673281Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Shanghai Zhongshan Hospital at 38 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kang Yao, M.D., Ph.D. (86+13818988550, yao.kang@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cardiac death (time frame: 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02496858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.