Correlation of Biomarkers With the Presence and Severity of Coronary Artery Disease

NCT05015270 | Completed DMC

• 1 other identifier: NMU20211033
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

The development of coronary artery disease is multifactorial. Peripheral blood biomarkers paly an important role in the prediction of coronary artery disease. However, the identification of those biomarkers and their correlation with the presence and severity of coronary artery disease are unclear. The present study aims to identify the differentially expressed biomarkers from peripheral blood between normal population and patients with different disease burden confirmed by coronary angiography, and to analyze the correlation of those biomarkers with the severity of coronary artery disease. Finally, the prediction of biomarkers for clinical events.

Conditions

Coronary Artery Disease

Keywords

Biomarkers, Coronary artery disease, Disease burden, Clinical events

Outcome Measures

Primary Outcomes (1)

• Correlation of biomarkers with coronary artery disease burden

  We will analyze the differential level of proteins in peripheral blood between three groups. As a result, the correlation between biomarkers with disease burden will analyzed.

  12 months

Secondary Outcomes (1)

• Clinical events

  12 months

Study Arms (2)

Less disease group

Patients with coronary artery diameter stenosis \<70% confirmed by coronary angiography; Patients will be treated using guideline recommended medications or percutaneous coronary intervention at physician's discretion

Diagnostic Test: Medications or percutaneous coronary intervention

Severe disease group

Patients with coronary artery stenosis ≥70% confirmed by coronary angiography; Patients will be treated using guideline recommended medications or percutaneous coronary intervention at physician's discretion

Diagnostic Test: Medications or percutaneous coronary intervention

Interventions

Medications or percutaneous coronary intervention DIAGNOSTIC_TEST

In this study, we will for the first analyze the correlation of proteins concentration with coronary artery disease burden. Next, the prediction of proteins for one-year clinical events will be further analyzed

Also known as: Percutaneous coronary intervention

Less disease group; Severe disease group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In geneal, the traditional risk factors for coronary artery disease (including age, sex, hypertension, diabetes, dyslipidemia, peripheral artery disease, smoker, fat, etc.) will be comparble between three groups (case-control).

You may qualify if:

• For Pilot study, both health and patients with at least one epicardial coronary artery disease are included
• For both Training group and Validation group, patients must have at least one epicardial coronary artery disease
• Left ventricular ejection fraction \> 30%
• Stable or unstable angina
• Myocardial infarction older than 1 month
• No active inflammation
• No scheduled non-cardiac surgery within 12 months
• eGFR \> 30 ml/min/m2
• Patients agree to participate in this study

You may not qualify if:

• Severe liver dysfunction
• Blood platelet count \<100 x 109/L
• Cancer
• On dialysis
• Pulmonary hypertension (defined as mean pulmonary arterial pressure \> 25 mmHg and pulmonary vessel resistance \> 3.0 Woods Unit)

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood will be collected from all patients after informal consent is obtained

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Shao-Liang M Chen, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 20, 2021
• Study Start: July 21, 2021
• Primary Completion: December 27, 2021
• Study Completion: December 30, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)