CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 3,974 enrolled
Drug / intervention
Exposure to genetics (polygenic)genetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05515653
NCT05515653N/AActive

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

Hospital Alemão Oswaldo Cruz·observational·Posted Aug 25, 2022·Updated May 30, 2024

In Brief

An observational study evaluating Exposure to genetics (polygenic) for Cardiovascular Diseases and 4 related conditions. Active but no longer recruiting, targeting 3,974 participants across 41 sites.

Detailed Summary

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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/AActiveOverdue
2023202420252026
First PostedAug 25, 2022
Enrollment StartJul 18, 2022
Primary CompletionFeb 20, 2023
Study CompletionJul 15, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.9 years ago

Interventions

Exposure to genetics (polygenic)genetic

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)