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NCT Number: NCT05015270

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

About this study

This study includes three parts:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other names: Percutaneous coronary intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Acronym: PREDICTION-NJ

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2021
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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