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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03315234
Enrollment
270
Registered
2017-10-20
Start date
2016-09-01
Completion date
2021-06-30
Last updated
2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor, Coronary Arteriosclerosis, Coronary Artery Disease

Keywords

SYNTAX score, Coronary Atherosclerosis, Coronary Artery Disease, SNPs, Genetics, Genetic Risk Score, Personalized Medicine

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.

Interventions

GENETICSNPs associated with CAD

Genotyping will be carried out by Real-Time PCR

Sponsors

LABNET IAE - Private Reference Diagnostic Laboratory
CollaboratorUNKNOWN
Aristotle University Of Thessaloniki
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Relationship between genetic risk variants and the SYNTAX score [All-comers population]12 monthsThe 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

MeasureTime frameDescription
Predictive value of combining a Genetic Risk Score & SYNTAX score for the prediction of 1-year MACCEs12 monthsA 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 IndexAt hospital admissionA tool for diagnosing peripheral artery disease but also an indicator of systemic atherosclerosis \[represented by a single number\]
Left Ventricular Ejection FractionAt hospital admission & 12 months after discharge from hospitalLVEF \[%\] as assessed by echocardiography
Neutrophil to Lymphocyte RatioAt hospital admissionNLR \[represented by a single number\]
MACCEs12 monthsCardiovascular death, myocardial infarction, stent thrombosis, any re-intervention and stroke
Mean Platelet VolumeAt hospital admissionMPV \[fL\]
Glomerular Filtration RateAt hospital admissionGFR as assessed by CKD-EPI formula \[mL/min/1.73m²\]
High Density LipoproteinAt hospital admissionHDL \[mg/dL\]
Red Cell Distribution WidthAt hospital admissionRDW \[%\]

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026