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NCT05515653

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

Sponsor: Hospital Alemão Oswaldo Cruz

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

3974

Start Date

2022-07-18

Completion Date

2024-07-15

Last Updated

2024-05-30

Healthy Volunteers

Yes

Interventions

GENETIC

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)

Locations (41)

Acurácia Serviços Médicos

Rio Branco, Acre, Brazil

Centro de Pesquisas Clínicas Dr. Marco Mota HCOR

Maceió, Alagoas, Brazil

Centro de Pesquisa Clínica do Coração

Aracaju, Ceará, Brazil

Hospital Maternidade São Vicente de Paulo

Barbalha, Ceará, Brazil

Hospital Evangélico de Vila Velha

Vila Velha, Espírito Santo, Brazil

Hospital Universitário Cassiano Antônio de Moraes

Vitória, Espírito Santo, Brazil

Hospital e Clínica São Roque

Ipiaú, Estado de Bahia, Brazil

Instituto Cárdio Pulmonar da Bahia

Salvador, Estado de Bahia, Brazil

Universidade Federal de Goiás - UFG

Goiânia, Goiás, Brazil

Hospital Universitário da Universidade Federal do Maranhão/HU/UFMA

São Luís, Maranhão, Brazil

Hospital Universitário Maria Aparecida Pedrossian

Campo Grande, Mato Grosso do Sul, Brazil

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Santa Casa de Misericórdia de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Hospital de Clínicas da Universidade Federal do Triângulo Mineiro

Uberaba, Minas Gerais, Brazil

Hospital Geral Filantrópico Universitário - Assoc. de Proteção à Maternidade e Infância de Cuiabá

Cuiabá, Mount, Brazil

Hospital e Maternidade Angelina Caron

Campina Grande do Sul, Paraná, Brazil

Núcleo de Pesquisa Clínica S/S

Curitiba, Paraná, Brazil

Real Hospital Português de Beneficência em Pernambuco

Recife, Pernambuco, Brazil

Hospital Universitário da Universidade Federal do Piauí

Teresina, Piauí, Brazil

Instituto Atena de Pesquisa Clínica

Natal, Rio Grande do Norte, Brazil

Associação Dr. Bartholomeu Tacchini

Bento Gonçalves, Rio Grande do Sul, Brazil

Associacao Hospitalar Beneficente Sao Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Santa Casa de Misericórdia de Pelotas

Pelotas, Rio Grande do Sul, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora Da Conceicao Sa

Porto Alegre, Rio Grande do Sul, Brazil

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Universitário de Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Maestri e Kormann Consultoria Medico Cientifica

Blumenau, Santa Catarina, Brazil

H&W Cardiologia LTDA

Joinville, Santa Catarina, Brazil

Hospital Cirurgia

Aracaju, Sergipe, Brazil

Hospital Municipal de Barueri

Barueri, São Paulo, Brazil

Instituto de Pesquisa Clínica de Campinas

Campinas, São Paulo, Brazil

Scentryfar Pesquisa Clínica

Campinas, São Paulo, Brazil

Hospital Carlos Fenando Malzoni

Matão, São Paulo, Brazil

Braile Hospital Dia Ltda

São José do Rio Preto, São Paulo, Brazil

Fundação Faculdade de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Hospital Alemão Oswaldo Cruz

São Paulo, São Paulo, Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

Instituto de Cardiologia HCFMUSP

São Paulo, São Paulo, Brazil

Instituto de Pesquisa GNDI

São Paulo, São Paulo, Brazil

Hospital Santa Paula

São Paulo, Brazil