Correlation of Biomarkers With the Presence and Severity of Coronary Artery Disease (PREDICTION-NJ)

March 26, 2022 updated by: Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University

Identification of Peripheral Blood Biomarkers for Prediction of Coronary Artery Disease Confirmed by Coronary Angiography

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study includes three parts:

  1. Part 1 (Pilot analysis): 30 normal people and 30 patients with at least one epicardial coronary artery disease confirmed by angiography will be included. 10 ml peripheral blood from arterial sheath (just before angiography) will be collected in each subject. Proteomics analyses are performed in order to obtain the differentially expressed proteins (coded by Proteins 1-x.
  2. Part 2 (Training group): Differentially expressed Proteins 1-x are measured and compared between patients with diameter stenosis <70% (n=100) vs. with diameter stenosis ≥ 70%(n=100), respectively. Finally, Proteins 1-y from Proteins 1-x will be identified. Subgroups stratified by single-, double-, and triple-vessel disease will be performed.
  3. Part 3 (Validation group): The difference in blood concentration of Proteins 1-y between patients with different disease burden will be further analyzed: patients with diameter stenosis <70% (n=200) vs. diameter stenosis ≥70% (n=200), respectively. Subgroups stratified by single-, double-, and triple-vessel disease will be performed.

Study Type

Observational

Enrollment (Actual)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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).

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Other Names:
  • 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
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
Other Names:
  • Percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of biomarkers with coronary artery disease burden
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical events
Time Frame: 12 months
Clinical events are a composite of cardiac death, myocardial infarction, revascularization, and stroke at one-year since coronary angiography
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Principal Investigator: Shao-Liang M Chen, MD, The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2021

Primary Completion (Actual)

December 27, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

August 18, 2021

First Submitted That Met QC Criteria

August 18, 2021

First Posted (Actual)

August 20, 2021

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 26, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMU20211033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No share IPD with others

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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