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Trial record 99 of 1448 for:    Prediction | Recruiting, Not yet recruiting, Available Studies

Development of a Risk Prediction Algorithm Through the Investigation of Genetic Risk Factors and the Complexity of Coronary Artery Disease to Estimate Future Risk of Cardiovascular Events: Angiographic (SYNTAX Score), Clinical and Pharmacogenetic Analysis. (GESS)

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ClinicalTrials.gov Identifier: NCT03150680
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : September 7, 2017
Sponsor:
Collaborator:
LABNET IAE - Private Reference Diagnostic Laboratory
Information provided by (Responsible Party):
Georgios Sianos, AHEPA University Hospital

Brief Summary:
The purpose of the research project is to investigate the potential association of 207 genetic polymorphisms with the complexity and the severity of coronary artery disease (SYNTAX score), along with the patients' response to clopidogrel and statin therapy. The aim of the study is to combine genetic, pharmacogenetic, clinical and laboratory data in order to create an algorithm (GEnetic Syntax Score-GESS) that will enable an individualized therapeutic patient approach.

Condition or disease Intervention/treatment
Coronary Artery Disease Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins

Detailed Description:
Regarding Greece, this is the first prospectively enrolling medical database of this magnitude. Clinical and genetic patient information are systematically collected in a fashion that will enable also future retrospective evaluation of clinical and genetic details from each patient. This study is a discrete arm of a series of research projects that focus on the development of personalized medical therapy and share a common purpose: predicting 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.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1080 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Development of a Risk Prediction Algorithm Through the Investigation of Genetic Risk Factors and the Complexity of Coronary Artery Disease to Estimate Future Risk of Cardiovascular Events: Angiographic (SYNTAX Score), Clinical and Pharmacogenetic Analysis.
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Clopidogrel

Group/Cohort Intervention/treatment
SYNTAX score = 0
Patients with nonobstructive CAD (≤50 % diameter stenosis)
Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins
Genotyping will be carried out by Next-Generation Sequencing (NGS)
Other Names:
  • Clinical information
  • Laboratory data

0 < SYNTAX score <23
Low SYNTAX group
Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins
Genotyping will be carried out by Next-Generation Sequencing (NGS)
Other Names:
  • Clinical information
  • Laboratory data

SYNTAX score >= 23
Intermediate-High SYNTAX group
Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins
Genotyping will be carried out by Next-Generation Sequencing (NGS)
Other Names:
  • Clinical information
  • Laboratory data




Primary Outcome Measures :
  1. Relationship between genetic risk variants and the SYNTAX score [ Time Frame: 12 months ]
    All-comers population


Secondary Outcome Measures :
  1. MACCEs [ Time Frame: 12 months ]
    Cardiovascular death, myocardial infarction, stent thrombosis, any re-intervention and stroke

  2. Predictive value of combining a Genetic Risk Score, SYNTAX score and clinical variables for the prediction of 1-year MACCEs [ Time Frame: 12 months ]

    A multilocus Genetic Risk Score will be calculated as the weighted sum of alleles of 207 single nucleotide polymorphisms previously associated with CAD [The investigators will construct a multilocus genetic risk score for each individual by summing the number of risk alleles (0/1/2) for each of the 207 SNPs weighted by their estimated effect sizes].

    SYNTAX score is a coronary lesion complexity scoring system and represented by a single number.

    Clinical variables include:

    1. Major CV risk factors as defined according to ESC Guidelines [as dichotomous variables-yes or no]
    2. Ankle-Brachial Index: a tool for diagnosing peripheral artery disease but also an indicator of systemic atherosclerosis [measurement according to ESC Guidelines-represented by a single number]
    3. Left Ventricular Ejection Fraction (LVEF%) using echocardiography.

  3. Any BARC (Bleeding Academic Research Consortium) bleeding [ Time Frame: 12 months ]
    Bleeding Academic Research Consortium (BARC) recently proposed a novel standardized bleeding definition


Biospecimen Retention:   Samples With DNA
DNA will be extracted from obtained subject blood samples at the AHEPA University General Hospital of Thessaloniki. DNAs will be labeled by anonymized subject ID # (de-identified), and shipped to LABNET IAE - Private Reference Diagnostic Laboratory for genotyping and genetic analysis.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients between 18 years to 90 years at entry, of both genders, who are admitted in the Department of Cardiology in the AHEPA University General Hospital of Thessaloniki and undergo coronary angiography for clinical purposes will be studied. Patients with a previous history of coronary artery disease will be excluded. The study includes subjects who 1) have suspected CAD and undergo a scheduled diagnostic angiogram for clinical reasons, and 2) are hospitalized because of an acute coronary syndrome and thus undergo diagnostic angiography (without previous history of CAD).
Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03150680


Contacts
Contact: Georgios Sianos, MD PhD FESC 0030 2310994830 gsianos@auth.gr

Locations
Greece
AHEPA University Hospital Recruiting
Thessaloníki, Greece, 54636
Contact: Georgios Sianos, MD, PhD    0030 2310994830    gsianos@auth.gr   
Principal Investigator: Georgios Sianos, MD,PhD,FESC         
Principal Investigator: Ioannis Vizirianakis, PharmD,PhD         
Principal Investigator: Dimitrios Chatzidimitriou, MD,PhD         
Principal Investigator: Georgios Rampidis, MD,MSc         
Sponsors and Collaborators
AHEPA University Hospital
LABNET IAE - Private Reference Diagnostic Laboratory
Investigators
Principal Investigator: Georgios Sianos, MD PhD FESC AHEPA University Hospital

Publications:
Responsible Party: Georgios Sianos, Associate Professor of Cardiology MD, PhD, FESC, AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT03150680     History of Changes
Other Study ID Numbers: CIP_GESS_Trial_1.1
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Georgios Sianos, AHEPA University Hospital:
SYNTAX score
SNPs
Genetics
Pharmacogenetics
Genetic Risk Score
Precision Medicine

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs