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Clinical trial

Impact of the Genetic Background as a Risk Factor for Atherosclerotic Cardiovascular Disease in the Brazilian Population

ID
Name
HAlemaoOswaldoCruz
Description
The main objective of this project is to evaluate the genomic information previously associated with cardiovascular diseases (CVD) and its importance as an independent risk predictor (expressed in Odds Ratio) when adjusted for traditional risk factors (smoking, diabetes, arterial hypertension, obesity , anxiety and depression, inadequate diet, physical inactivity, alcohol consumption and apolipoprotein B/A1 ratio (ApoB/ApoA1). An unpaired case-control study of individuals over 18 years of age will be carried out. Cases (N = 1867) will be enrolled right after the occurrence of the first atherosclerotic cardiovascular event (Acute Myocardial Infarction, Stroke and Peripheral Artery Thrombotic-Ischemic Events). The ratio between cases and controls will be 1:1. The controls (N = 1867) will be adult individuals over 18 years of age who sought medical care at the same locations for other clinical reasons (no CVD) or individuals without any overt disease. The genetic evaluation will be performed through the association of Low-covering Whole Genome Sequencing (coverage 0.5-5x) and Whole Exome Sequencing (average coverage 30x).
Trial arms
Trial start
2022-07-18
Estimated PCD
2023-02-20
Trial end
2024-07-15
Status
Active (not recruiting)
Treatment
Exposure to genetics (polygenic)
The polygenic risk score (PRS) aggregates the effects of genetic variants into a single number that predicts the genetic predisposition to a phenotype. PRS are typically composed of hundreds to millions of genetic variants, usually Single Nucleotide Polymorphisms (SNPs). For each individual, the number of risk alleles computed in each variant is summed and weighted by the estimated value of the obtained effects (log odds ratio for traits with binary values or Beta coefficients for traits with continuous value) obtained from large-scale genomic studies ( GWAS)
Arms:
Case - atherosclerotic cardiovascular disease, Control - without atherosclerotic cardiovascular disease ou healthy
Other names:
polygenic risk score
Size
3974
Primary endpoint
Population attributable risk fraction measured for the Polygenic Risk Score. Scale will range from 0 to maximum number of risk alleles. The higher the score, the higher the number of risk alleles (worse).
through study completion, an average of 1 year
Polymorphisms genes as an independent risk factor for the occurrence of Acute Myocardial infarction (AMI), stroke and peripherical arterial thrombotic-ischemic events
through study completion, an average of 1 year
Eligibility criteria
Inclusion Criteria: * Cases: adults over 18 years with first atherosclerotic cardiovascular event (Acute Myocardial Infarction, Stroke and Peripheral Artery Thrombotic-Ischemic Events) * Controls: adult individuals over 18 years of age who sought medical care at the same locations for other clinical reasons (no CVD) or individuals without any overt disease Exclusion Criteria: * Previous occurrence of Cardiovascular Event (Myocardial Infarction, Stroke or Peripheral Artery Thrombotic Events * Patients already recruited in another study linked to the GENOMA Brazil Program.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Total blood, Buffy Coat'}, 'enrollmentInfo': {'count': 3974, 'type': 'ACTUAL'}}
Updated at
2024-05-30

1 organization

1 product

5 indications

Organization
Hospital Alemão Oswaldo Cruz
Product
Exposure to genetics
Indication
Cardiovascular Diseases
Indication
Acute Myocardial Infarction
Indication
stroke
Indication
Peripheric Vascular Enfermedad
Indication
Genetic Predisposition to Disease