Mechanism and Intervention Research of Atherosclerosis

NCT05437107 | Completed DMC

• 1 other identifier: 2016-I2M-1-009
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with atherosclerosis are at high risk of future cardiovascular disease. Approximately 70% cardiac death and 50% myocardial infarction (MI) occurred among patients with established coronary artery disease (CAD). These patients have a four to seven-fold risk of fatal or non-fatal MI compared with those without CAD. Current secondary prevention therapy, including statins and anti-platelet therapy have decreased mortality among CHD patients. However, one out of five patients with MI experienced cardiovascular events within one-year of discharge. This study aims at identifying new risk factors of atherosclerosis, improving risk-stratification among patients with CAD by using novel biomarkers and finally improving outcome and life quality of patients. The investigators will recruit 30000 patients undergoing elective elective coronary angiography and collect baseline characteristics, physical examination, lab test results, angiographic characteristics, etc. Blood sample will also be collected at baseline. Subsequently, two-year follow-up will be done to collect data regarding patients' outcome, including cardiac death, MI, revascularization, medication, etc. Investigators will compare baseline, imaging, blood test results between patients with and without cardiovascular events and identify novel predictors of the occurrence and progression of CAD.

Conditions

Atherosclerosis

Keywords

mechanism; biomarker; atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events (MACE)

  death, nonfatal myocardial infarction, repeat revascularization

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suspected of CAD and underwent elective coronary angiogram. Patients have signed written informed consent

You may qualify if:

• Undergo elective coronary angiography in department of cardiology in period of study
• Written informed consent

You may not qualify if:

• Age ≤18 years of age
• Unable to sign consent
• Other severe comorbidities with life expectancy \<1 year

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

Study Sites (1)

Yuejin Yang

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yuejin Yang, MD, PhD

  National Center for Cardiovascular Diseases; Fuwai Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: January 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)