Correlation of Genetic Polymorphisms and Clinical Parameters With the Complexity of Coronary Artery Disease

• Conditions: Coronary Arteriosclerosis; Coronary Artery Disease; Cardiovascular Risk Factor
• Interventions: Genetic: SNPs associated with CAD

• Registration Number: NCT03315234
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

The purpose of the research project is to investigate the potential association of 6 genetic polymorphisms with the complexity and the severity of coronary artery disease (SYNTAX score). The aim of the study is to combine genetic, clinical and laboratory data in order to create a prognostic tool that will enable an individualized therapeutic patient approach.

Detailed Description

This study focus on the prediction of future risk of cardiovascular events, assessing the severity and complexity of coronary artery disease by incorporating genetic information into the SYNTAX score and providing personalized therapeutic guidance to patients. The ultimate goal of the study would be to identify, design and develop a panel of genetic markers that in combination with clinical and angiographic information will be a reliable tool for predicting cardiovascular risk for future adverse events. Clinical and genetic patient information are systematically collected in a fashion that will enable also retrospective evaluation.

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2017-10-10
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-20
• Primary Completion: 2018-06-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-07
• Last Update Posted: 2020-06-09
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

1. Patients who are admitted in the Department of Cardiology in the AHEPA University General Hospital of Thessaloniki and undergo coronary angiography for clinical purposes
2. Patients giving voluntary written consent to participate in the study
3. Male or female patients between 18 years to 90 years at entry
4. Patients without previous history of CAD

Exclusion Criteria

1. Patients < 18 years old and > 90 years old at time of coronary angiography
2. Patients with a previous history of CAD
3. Cardiac Arrest at admission
4. Patients with serious concurrent disease and life expectancy of < 1 year
5. Patients who refuse to give written consent for participation in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
0 < SYNTAX score < 23	SNPs associated with CAD	Low SYNTAX group
SYNTAX score = 0	SNPs associated with CAD	Patients with nonobstructive CAD (≤50 % diameter stenosis)
SYNTAX score ≥ 23	SNPs associated with CAD	Intermediate-High SYNTAX group

Primary Outcome Measures

Name	Time	Method
Relationship between genetic risk variants and the SYNTAX score [All-comers population]	12 months	The investigators will evaluate the effects of 6 known genetic variants associated with risk of Coronary Artery Disease on the extend and severity of coronary atherosclerosis \[as assessed by the SYNTAX score\] in patients with significant CAD on coronary angiography, both individually and combined in a Genetic Risk Score

Secondary Outcome Measures

Name	Time	Method
Mean Platelet Volume	At hospital admission	MPV \[fL\]
High Density Lipoprotein	At hospital admission	HDL \[mg/dL\]
Glomerular Filtration Rate	At hospital admission	GFR as assessed by CKD-EPI formula \[mL/min/1.73m²\]
MACCEs	12 months	Cardiovascular death, myocardial infarction, stent thrombosis, any re-intervention and stroke
Predictive value of combining a Genetic Risk Score & SYNTAX score for the prediction of 1-year MACCEs	12 months	A Genetic Risk Score will be calculated as the weighted sum of alleles of 6 single nucleotide polymorphisms previously associated with CAD \[The GRS will be constructed by summing the number of risk alleles (0/1/2) for each of the 6 SNPs weighted by their estimated effect sizes\].; SYNTAX score is a coronary lesion complexity scoring system and represented by a single number.
Ankle-Brachial Index	At hospital admission	A tool for diagnosing peripheral artery disease but also an indicator of systemic atherosclerosis \[represented by a single number\]
Left Ventricular Ejection Fraction	At hospital admission & 12 months after discharge from hospital	LVEF \[%\] as assessed by echocardiography
Neutrophil to Lymphocyte Ratio	At hospital admission	NLR \[represented by a single number\]
Red Cell Distribution Width	At hospital admission	RDW \[%\]

Trial Locations

Locations (1)

AHEPA University Hospital; 🇬🇷 Thessaloníki, Greece