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Trial record 17 of 569 for:    Genetic AND SNP

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03315234
Recruitment Status : Active, not recruiting
First Posted : October 20, 2017
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
LABNET IAE - Private Reference Diagnostic Laboratory
Information provided by (Responsible Party):
Georgios P Rampidis, MD, MSc, 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.

Condition or disease Intervention/treatment
Coronary Artery Disease Cardiovascular Risk Factor Coronary Arteriosclerosis Genetic: SNPs associated with CAD

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Correlation of Genetic Polymorphisms and Clinical Parameters With the Complexity of Coronary Artery Disease in the Greek Population
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
SYNTAX score = 0
Patients with nonobstructive CAD (≤50 % diameter stenosis)
Genetic: SNPs associated with CAD
Genotyping will be carried out by Real-Time PCR

0 < SYNTAX score < 23
Low SYNTAX group
Genetic: SNPs associated with CAD
Genotyping will be carried out by Real-Time PCR

SYNTAX score ≥ 23
Intermediate-High SYNTAX group
Genetic: SNPs associated with CAD
Genotyping will be carried out by Real-Time PCR




Primary Outcome Measures :
  1. Relationship between genetic risk variants and the SYNTAX score [All-comers population] [ Time Frame: 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 :
  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 for the prediction of 1-year MACCEs [ Time Frame: 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.


  3. Ankle-Brachial Index [ Time Frame: At hospital admission ]
    A tool for diagnosing peripheral artery disease but also an indicator of systemic atherosclerosis [represented by a single number]

  4. Left Ventricular Ejection Fraction [ Time Frame: At hospital admission & 12 months after discharge from hospital ]
    LVEF [%] as assessed by echocardiography

  5. Neutrophil to Lymphocyte Ratio [ Time Frame: At hospital admission ]
    NLR [represented by a single number]

  6. Red Cell Distribution Width [ Time Frame: At hospital admission ]
    RDW [%]

  7. Mean Platelet Volume [ Time Frame: At hospital admission ]
    MPV [fL]

  8. Glomerular Filtration Rate [ Time Frame: At hospital admission ]
    GFR as assessed by CKD-EPI formula [mL/min/1.73m²]

  9. High Density Lipoprotein [ Time Frame: At hospital admission ]
    HDL [mg/dL]


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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

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): NCT03315234


Locations
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Greece
AHEPA University Hospital
Thessaloníki, Greece, 54636
Sponsors and Collaborators
Aristotle University Of Thessaloniki
LABNET IAE - Private Reference Diagnostic Laboratory
Investigators
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Principal Investigator: Georgios Rampidis, MD, MSc AHEPA University Hospital, 1st Cardiology Department - PhD candidate
Principal Investigator: Georgios Sianos, MD, PhD, FESC AHEPA University Hospital, 1st Cardiology Department - PhD Supervisor 1
Principal Investigator: Charalambos Karvounis, MD, PhD AHEPA University Hospital, 1st Cardiology Department, Director - PhD Supervisor 2
Principal Investigator: Ioannis Vizirianakis, PharmD, PhD Aristotle University of Thessaloniki, School of Pharmacy - PhD Supervisor 3

Additional Information:

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: NCT03150680
GESS trial [ClinicalTrials.gov Identifier: NCT03150680] was designed exclusively based on the protocol of the study "Correlation of Genetic Polymorphisms and Clinical Parameters With the Complexity of Coronary Artery Disease" [CIP_PhD Rampidis Georgios_1.1]

Publications:
Howson JMM, Zhao W, Barnes DR, Ho WK, Young R, Paul DS, Waite LL, Freitag DF, Fauman EB, Salfati EL, Sun BB, Eicher JD, Johnson AD, Sheu WHH, Nielsen SF, Lin WY, Surendran P, Malarstig A, Wilk JB, Tybjærg-Hansen A, Rasmussen KL, Kamstrup PR, Deloukas P, Erdmann J, Kathiresan S, Samani NJ, Schunkert H, Watkins H; CARDIoGRAMplusC4D, Do R, Rader DJ, Johnson JA, Hazen SL, Quyyumi AA, Spertus JA, Pepine CJ, Franceschini N, Justice A, Reiner AP, Buyske S, Hindorff LA, Carty CL, North KE, Kooperberg C, Boerwinkle E, Young K, Graff M, Peters U, Absher D, Hsiung CA, Lee WJ, Taylor KD, Chen YH, Lee IT, Guo X, Chung RH, Hung YJ, Rotter JI, Juang JJ, Quertermous T, Wang TD, Rasheed A, Frossard P, Alam DS, Majumder AAS, Di Angelantonio E, Chowdhury R; EPIC-CVD, Chen YI, Nordestgaard BG, Assimes TL, Danesh J, Butterworth AS, Saleheen D. Fifteen new risk loci for coronary artery disease highlight arterial-wall-specific mechanisms. Nat Genet. 2017 Jul;49(7):1113-1119. doi: 10.1038/ng.3874. Epub 2017 May 22.

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Responsible Party: Georgios P Rampidis, MD, MSc, Principal Investigator, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT03315234     History of Changes
Other Study ID Numbers: CIP_PhD Rampidis Georgios_1.1
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Georgios P Rampidis, MD, MSc, Aristotle University Of Thessaloniki:
SYNTAX score
Coronary Atherosclerosis
Coronary Artery Disease
SNPs
Genetics
Genetic Risk Score
Personalized Medicine

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases