Coronary Artery DiseaseNCT06362278
A Multi-omics Study of "Healthy" Premature CAD Patients
An observational study of Coronary Artery Disease, run by The First Affiliated Hospital with Nanjing Medical University at 3 sites in China.
Trial summary
The goal of this multi-center observational clinical trial is to investigate the genetic risk factors of patients with premature CAD and none traditional CAD risk factors through a multi-omics approach. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- multi-omics studies
- How many people
- 160 participants
- Where
- 3 sitesChina
- Study dates
- 20 Mar 2024to Dec 2025
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In-patients from cardiology department of either following 3 hospitals: a) The First Affiliated Hospital of Nanjing Medical University; b) Qilu Hospital of Shandong University; c) The Second Affiliated Hospital Zhejiang University School of Medicine. Those patients who meet the criteria for cases or controls and willing to give an informed consent will be enrolled.
Who may be able to join
- In-patients from cardiology department of either following 3 hospitals: a) The First Affiliated Hospital of Nanjing Medical University; b) Qilu Hospital of Shandong University; c) The Second Affiliated Hospital Zhejiang University School of Medicine
- Confirmed diagnosis of Obstructive CAD (≥50% diameter stenosis in a major epicardial vessel) through coronary angiography
- Age of the patient when Obstructive CAD was for the first time diagnosed should be no more than 45 years old for the male and 55 years old for the female.
- In-patients from cardiology department of either following 3 hospitals: a) The First Affiliated Hospital of Nanjing Medical University; b) Qilu Hospital of Shandong University; c) The Second Affiliated Hospital Zhejiang University School of Medicine
- Coronary artery stenosis was ruled out through either coronary angiography or coronary CTA.
Who cannot join
- Patients with hypertension (grade 1-3)
- Patients with type 1 or type 2 diabetes mellitus
- BMI >28.0 Kg/m^2
- Patients with non-ideal blood lipids level on admission(defined as either LDL-C≥2.6mmol/L OR non-HDL cholesterol≥3.4mmol/L OR Lipoprotein(a) ≥300mg/L)
- Smoker (Smoking for more than 6 consecutive or cumulative months in a lifetime, whether quit smoking or not)
- Patients with hyperuricemia or gout
Show all 9Show fewer
- eGFR<60 ml/min·1.73m^2
- Patients with structural heart diseases, inherited cardiomyopathies \& arrhythmias
- Other reasons a participant considered unsuitable for inclusion by researchers.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 1 recruiting
- Active, not recruiting
The Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, 310009
- Active, not recruiting
Qilu Hospital of Shangdong University
Jinan, Shandong, 250012
- Recruiting
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Chunjian Li, Phd、MD, +86 13701465229, lijay@njmu.edu.cn
About this study
Official title: A Multi-omics Study of Patients With Premature Coronary Artery Disease in the Absence of Common Risk Factors
The goal of this multi-center observational clinical trial is to investigate the genetic risk factors of patients with premature CAD and none traditional CAD risk factors through a multi-omics approach.
The main questions it aims to answer are:
- Genetic risk factors \& metabolic fingerprints of patients with premature CAD and none traditional CAD risk factors remain unknown.
- How to optimize current primary prevention strategy for this rare CAD subgroup？
Read the detailed description
Cardiovascular diseases (CVDs) remain the leading cause of global mortality despite continuous efforts in disease prevention and treatment optimization. In 2022 alone, CVD caused an estimated 19.8 million deaths worldwide, and ischemic heart disease had the highest global age-standardized DALYs of all diseases at 2,275.9 per 100,000. Therefore, research on the etiology and pathogenesis of coronary artery disease (CAD) remains first priority.
It is now widely known that risk factors such as diabetes mellitus, hyperlipidemia, hypertension, smoking, and obesity are closely related to CAD, but they only explain 30%-40% of CAD risk factors, and large-sample cohort and twin studies have concluded that CAD heritability is estimated to be 40% to 60%. With the development of the Human Genome Project and high-throughput sequencing technology, in the past decade, increasingly larger genome-wide association studies (GWAS) have been conducted worldwide and biobanks established. Public sequencing data is increasingly being used as external common controls instead of sequencing new controls in every study. Till now, thousands of mutations related to CAD have been identified. Multiple Polygenic risk scores (PRSs) have been developed to improve the prediction of common, complex cardiovascular diseases like CAD on individual level.
Premature CAD has been proved to have strong link with family history of cardiovascular and cerebral vascular disease, which indicates a strong genetic background of premature CAD. However, there is an even more scarce \& inconspicuous subgroup of premature CAD, defined as premature CAD without common CAD risk factors in this study. First of all, most of those patients were considered "healthy" or "at very low risk of CVDs" before CAD was diagnosed; secondly, genetic risk factors \& metabolic fingerprints of such patients remain unknown; thirdly, we still don't know yet how to optimize current primary prevention strategy for this rare CAD subgroup.
For this regard, we designed this multi-omics study to cover the questions mentioned above.
- Conditions
- Coronary Artery Disease
- Being tested
- multi-omics studies
- Keywords
- coronary artery disease, multi-omics, premature
- Medical subject headings
- Coronary Artery Disease, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-omics studiesOther
15cc peripheral venous blood will be collected for multi-omics studies, including whole-exome study, transcriptomics \& metabolomics studies.
| Study group | Role | What they receive |
|---|---|---|
| cases group | In-patients from cardiology department of The First Affiliated Hospital with Nanjing Medical University will be screened using inclusion/exclusion criteria for patients. Among the patients who meet the criteria and willing to give an informed consent, 30 patients with youngest CAD-diagnosed-age will be enrolled as cases. Receives: Other: multi-omics studies | |
| matching controls group | In-patients from cardiology department of The First Affiliated Hospital with Nanjing Medical University will be screened using inclusion/exclusion criteria for controls. 30 controls matched in gender and age will be enrolled as matching controls. Receives: Other: multi-omics studies | |
| verification group | In-patients from cardiology departments of all 3 centers will be screened using inclusion/exclusion criteria. Other than previous 60 participants, about another 100 patients and controls in total who meet the criteria and willing to give an informed consent will be enrolled as verification group. Receives: Other: multi-omics studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
common & rare variants associated with "healthy" pre-mature CAD phenotype
Whole-exome study in both patients and matching controls will be pefromed using rare-variant collapsing analyses to findout common \& rare variants accosicated with this phenotype. Relative variants will be further screend \& validated in verification group. If necessary, further casade screening using trios-wes technique will be perfromed within certain families under written consent.
Measured: 3 months
Unique metabolomic fingerprints associated with "healthy" pre-mature CAD phenotype
Non-targeted metabonomic analysis of plasma will be performed in both patients and matching controls. Relative metabolites will be further screend \& validated in verification group. If necessary, further targeted metabonomic analysis will be performed using redundant serum samples .
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start20 Mar 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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 The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjian Li, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Chunjian Li, PHD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362278
- Sponsor's protocol ID
- 026
- Status last verified
- Apr 2024
- First submitted
- 5 Jan 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual level data will not be published until further permission granted from domestic Human Genetic Resource Administration.
Publications
Mensah GA, Fuster V, Murray CJL, Roth GA; Global Burden of Cardiovascular Diseases and Risks Collaborators. Global Burden of Cardiovascular Diseases and Risks, 1990-2022. J Am Coll Cardiol. 2023 Dec 19;82(25):2350-2473. doi: 10.1016/j.jacc.2023.11.007. No abstract available.
PubMed 38092509Kessler T, Vilne B, Schunkert H. The impact of genome-wide association studies on the pathophysiology and therapy of cardiovascular disease. EMBO Mol Med. 2016 Jul 1;8(7):688-701. doi: 10.15252/emmm.201506174. Print 2016 Jul.
PubMed 27189168O'Sullivan JW, Raghavan S, Marquez-Luna C, Luzum JA, Damrauer SM, Ashley EA, O'Donnell CJ, Willer CJ, Natarajan P; American Heart Association Council on Genomic and Precision Medicine; Council on Clinical Cardiology; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Lifestyle and Cardiometabolic Health; and Council on Peripheral Vascular Disease. Polygenic Risk Scores for Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2022 Aug 23;146(8):e93-e118. doi: 10.1161/CIR.0000000000001077. Epub 2022 Jul 18.
PubMed 35862132Muse ED, Chen SF, Torkamani A. Monogenic and Polygenic Models of Coronary Artery Disease. Curr Cardiol Rep. 2021 Jul 1;23(8):107. doi: 10.1007/s11886-021-01540-0.
PubMed 34196841Saadatagah S, Varughese MG, Nambi V. Coronary Artery Disease Risk Prediction in Young Adults: How Can We Overcome the Dominant Effect of Age? Curr Atheroscler Rep. 2023 Jun;25(6):257-265. doi: 10.1007/s11883-023-01106-1. Epub 2023 May 17.
PubMed 37195598Vilne B, Schunkert H. Integrating Genes Affecting Coronary Artery Disease in Functional Networks by Multi-OMICs Approach. Front Cardiovasc Med. 2018 Jul 17;5:89. doi: 10.3389/fcvm.2018.00089. eCollection 2018.
PubMed 30065929Collet JP, Zeitouni M, Procopi N, Hulot JS, Silvain J, Kerneis M, Thomas D, Lattuca B, Barthelemy O, Lavie-Badie Y, Esteve JB, Payot L, Brugier D, Lopes I, Diallo A, Vicaut E, Montalescot G; ACTION Study Group. Long-Term Evolution of Premature Coronary Artery Disease. J Am Coll Cardiol. 2019 Oct 15;74(15):1868-1878. doi: 10.1016/j.jacc.2019.08.1002.
PubMed 31601367Navas-Nacher EL, Colangelo L, Beam C, Greenland P. Risk factors for coronary heart disease in men 18 to 39 years of age. Ann Intern Med. 2001 Mar 20;134(6):433-9. doi: 10.7326/0003-4819-134-6-200103200-00007.
PubMed 11255518Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e596-e646. doi: 10.1161/CIR.0000000000000678. Epub 2019 Mar 17. No abstract available.
PubMed 30879355Singh A, Collins BL, Gupta A, Fatima A, Qamar A, Biery D, Baez J, Cawley M, Klein J, Hainer J, Plutzky J, Cannon CP, Nasir K, Di Carli MF, Bhatt DL, Blankstein R. Cardiovascular Risk and Statin Eligibility of Young Adults After an MI: Partners YOUNG-MI Registry. J Am Coll Cardiol. 2018 Jan 23;71(3):292-302. doi: 10.1016/j.jacc.2017.11.007. Epub 2017 Nov 12.
PubMed 29141201Wojcik GL, Murphy J, Edelson JL, Gignoux CR, Ioannidis AG, Manning A, Rivas MA, Buyske S, Hendricks AE. Opportunities and challenges for the use of common controls in sequencing studies. Nat Rev Genet. 2022 Nov;23(11):665-679. doi: 10.1038/s41576-022-00487-4. Epub 2022 May 17.
PubMed 35581355
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-omics Study of Patients With Premature Coronary Artery Disease in the Absence of Common Risk Factors
- ClinicalTrials.gov ID
- NCT06362278
- Acronym / sponsor ID
- 026
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, multi-omics, premature
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Apr 2024 (actual)
- 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 goal of this multi-center observational clinical trial is to investigate the genetic risk factors of patients with premature CAD and none traditional CAD risk factors through a multi-omics approach.
The main questions it aims to answer are:
- Genetic risk factors \& metabolic fingerprints of patients with premature CAD and none traditional CAD risk factors remain unknown.
- How to optimize current primary prevention strategy for this rare CAD subgroup？
Detailed description
Cardiovascular diseases (CVDs) remain the leading cause of global mortality despite continuous efforts in disease prevention and treatment optimization. In 2022 alone, CVD caused an estimated 19.8 million deaths worldwide, and ischemic heart disease had the highest global age-standardized DALYs of all diseases at 2,275.9 per 100,000. Therefore, research on the etiology and pathogenesis of coronary artery disease (CAD) remains first priority.
It is now widely known that risk factors such as diabetes mellitus, hyperlipidemia, hypertension, smoking, and obesity are closely related to CAD, but they only explain 30%-40% of CAD risk factors, and large-sample cohort and twin studies have concluded that CAD heritability is estimated to be 40% to 60%. With the development of the Human Genome Project and high-throughput sequencing technology, in the past decade, increasingly larger genome-wide association studies (GWAS) have been conducted worldwide and biobanks established. Public sequencing data is increasingly being used as external common controls instead of sequencing new controls in every study. Till now, thousands of mutations related to CAD have been identified. Multiple Polygenic risk scores (PRSs) have been developed to improve the prediction of common, complex cardiovascular diseases like CAD on individual level.
Premature CAD has been proved to have strong link with family history of cardiovascular and cerebral vascular disease, which indicates a strong genetic background of premature CAD. However, there is an even more scarce \& inconspicuous subgroup of premature CAD, defined as premature CAD without common CAD risk factors in this study. First of all, most of those patients were considered "healthy" or "at very low risk of CVDs" before CAD was diagnosed; secondly, genetic risk factors \& metabolic fingerprints of such patients remain unknown; thirdly, we still don't know yet how to optimize current primary prevention strategy for this rare CAD subgroup.
For this regard, we designed this multi-omics study to cover the questions mentioned above.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cases group | – | Other: multi-omics studiesIn-patients from cardiology department of The First Affiliated Hospital with Nanjing Medical University will be screened using inclusion/exclusion criteria for patients. Among the patients who meet the criteria and willing to give an informed consent, 30 patients with youngest CAD-diagnosed-age will be enrolled as cases. |
| matching controls group | – | Other: multi-omics studiesIn-patients from cardiology department of The First Affiliated Hospital with Nanjing Medical University will be screened using inclusion/exclusion criteria for controls. 30 controls matched in gender and age will be enrolled as matching controls. |
| verification group | – | Other: multi-omics studiesIn-patients from cardiology departments of all 3 centers will be screened using inclusion/exclusion criteria. Other than previous 60 participants, about another 100 patients and controls in total who meet the criteria and willing to give an informed consent will be enrolled as verification group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In-patients from cardiology department of either following 3 hospitals: a) The First Affiliated Hospital of Nanjing Medical University; b) Qilu Hospital of Shandong University; c) The Second Affiliated Hospital Zhejiang University School of Medicine. Those patients who meet the criteria for cases or controls and willing to give an informed consent will be enrolled.
Key inclusion criteria (5 listed)
- In-patients from cardiology department of either following 3 hospitals: a) The First Affiliated Hospital of Nanjing Medical University; b) Qilu Hospital of Shandong University; c) The Second Affiliated Hospital Zhejiang University School of Medicine
- Confirmed diagnosis of Obstructive CAD (≥50% diameter stenosis in a major epicardial vessel) through coronary angiography
- Age of the patient when Obstructive CAD was for the first time diagnosed should be no more than 45 years old for the male and 55 years old for the female.
- In-patients from cardiology department of either following 3 hospitals: a) The First Affiliated Hospital of Nanjing Medical University; b) Qilu Hospital of Shandong University; c) The Second Affiliated Hospital Zhejiang University School of Medicine
- Coronary artery stenosis was ruled out through either coronary angiography or coronary CTA.
Key exclusion criteria (9 listed)
- Patients with hypertension (grade 1-3)
- Patients with type 1 or type 2 diabetes mellitus
- BMI >28.0 Kg/m^2
- Patients with non-ideal blood lipids level on admission(defined as either LDL-C≥2.6mmol/L OR non-HDL cholesterol≥3.4mmol/L OR Lipoprotein(a) ≥300mg/L)
- Smoker (Smoking for more than 6 consecutive or cumulative months in a lifetime, whether quit smoking or not)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi-omics studies15cc peripheral venous blood will be collected for multi-omics studies, including whole-exome study, transcriptomics \& metabolomics studies. | Other | cases group, matching controls group, verification group |
Primary outcome
common & rare variants associated with "healthy" pre-mature CAD phenotype
Time frame: 3 months
Whole-exome study in both patients and matching controls will be pefromed using rare-variant collapsing analyses to findout common \& rare variants accosicated with this phenotype. Relative variants will be further screend \& validated in verification group. If necessary, further casade screening using trios-wes technique will be perfromed within certain families under written consent.
Unique metabolomic fingerprints associated with "healthy" pre-mature CAD phenotype
Time frame: 3 months
Non-targeted metabonomic analysis of plasma will be performed in both patients and matching controls. Relative metabolites will be further screend \& validated in verification group. If necessary, further targeted metabonomic analysis will be performed using redundant serum samples .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Background: PubMed 38092509Mensah GA, Fuster V, Murray CJL, Roth GA; Global Burden of Cardiovascular Diseases and Risks Collaborators. Global Burden of Cardiovascular Diseases and Risks, 1990-2022. J Am Coll Cardiol. 2023 Dec 19;82(25):2350-2473. doi: 10.1016/j.jacc.2023.11.007. No abstract available.
- Background: PubMed 27189168Kessler T, Vilne B, Schunkert H. The impact of genome-wide association studies on the pathophysiology and therapy of cardiovascular disease. EMBO Mol Med. 2016 Jul 1;8(7):688-701. doi: 10.15252/emmm.201506174. Print 2016 Jul.
- Background: PubMed 35862132O'Sullivan JW, Raghavan S, Marquez-Luna C, Luzum JA, Damrauer SM, Ashley EA, O'Donnell CJ, Willer CJ, Natarajan P; American Heart Association Council on Genomic and Precision Medicine; Council on Clinical Cardiology; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Lifestyle and Cardiometabolic Health; and Council on Peripheral Vascular Disease. Polygenic Risk Scores for Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2022 Aug 23;146(8):e93-e118. doi: 10.1161/CIR.0000000000001077. Epub 2022 Jul 18.
- Background: PubMed 34196841Muse ED, Chen SF, Torkamani A. Monogenic and Polygenic Models of Coronary Artery Disease. Curr Cardiol Rep. 2021 Jul 1;23(8):107. doi: 10.1007/s11886-021-01540-0.
- Background: PubMed 37195598Saadatagah S, Varughese MG, Nambi V. Coronary Artery Disease Risk Prediction in Young Adults: How Can We Overcome the Dominant Effect of Age? Curr Atheroscler Rep. 2023 Jun;25(6):257-265. doi: 10.1007/s11883-023-01106-1. Epub 2023 May 17.
- Background: PubMed 30065929Vilne B, Schunkert H. Integrating Genes Affecting Coronary Artery Disease in Functional Networks by Multi-OMICs Approach. Front Cardiovasc Med. 2018 Jul 17;5:89. doi: 10.3389/fcvm.2018.00089. eCollection 2018.
- Background: PubMed 31601367Collet JP, Zeitouni M, Procopi N, Hulot JS, Silvain J, Kerneis M, Thomas D, Lattuca B, Barthelemy O, Lavie-Badie Y, Esteve JB, Payot L, Brugier D, Lopes I, Diallo A, Vicaut E, Montalescot G; ACTION Study Group. Long-Term Evolution of Premature Coronary Artery Disease. J Am Coll Cardiol. 2019 Oct 15;74(15):1868-1878. doi: 10.1016/j.jacc.2019.08.1002.
- Background: PubMed 11255518Navas-Nacher EL, Colangelo L, Beam C, Greenland P. Risk factors for coronary heart disease in men 18 to 39 years of age. Ann Intern Med. 2001 Mar 20;134(6):433-9. doi: 10.7326/0003-4819-134-6-200103200-00007.
- Background: PubMed 30879355Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e596-e646. doi: 10.1161/CIR.0000000000000678. Epub 2019 Mar 17. No abstract available.
- Background: PubMed 29141201Singh A, Collins BL, Gupta A, Fatima A, Qamar A, Biery D, Baez J, Cawley M, Klein J, Hainer J, Plutzky J, Cannon CP, Nasir K, Di Carli MF, Bhatt DL, Blankstein R. Cardiovascular Risk and Statin Eligibility of Young Adults After an MI: Partners YOUNG-MI Registry. J Am Coll Cardiol. 2018 Jan 23;71(3):292-302. doi: 10.1016/j.jacc.2017.11.007. Epub 2017 Nov 12.
- Background: PubMed 35581355Wojcik GL, Murphy J, Edelson JL, Gignoux CR, Ioannidis AG, Manning A, Rivas MA, Buyske S, Hendricks AE. Opportunities and challenges for the use of common controls in sequencing studies. Nat Rev Genet. 2022 Nov;23(11):665-679. doi: 10.1038/s41576-022-00487-4. Epub 2022 May 17.
- Individual participant dataSharing planned: No. Individual level data will not be published until further permission granted from domestic Human Genetic Resource Administration.
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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.
Chunjian Li, PHD principal investigator
The First Affiliated Hospital with Nanjing Medical University
3 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, run by The First Affiliated Hospital with Nanjing Medical University at 3 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 5 inclusion and 9 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 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Chunjian Li, PHD (+86 13701465229, lijay@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
common & rare variants associated with "healthy" pre-mature CAD phenotype (time frame: 3 months). The study lists 2 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 NCT06362278, which also lists 11 linked publications.
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 12 Apr 2024.