Clinical trial NCT05015270: Correlation of Biomarkers With the Presence and Severity of Coronary Artery Disease
Official title: Identification of Peripheral Blood Biomarkers for Prediction of Coronary Artery Disease Confirmed by Coronary Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Biomarkers, Coronary artery disease, Disease burden, Clinical events
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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).

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Correlation of biomarkers with coronary artery disease burden
timeFrame: 12 months
Secondary outcomes:
measure: Clinical events
timeFrame: 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Shao-Liang M Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: