Impact of the Genetic Background as a Risk Factor for Atherosclerotic Cardiovascular Disease in the Brazilian Population
NCT ID: NCT05515653
Last Updated: 2024-05-30
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
3974 participants
OBSERVATIONAL
2022-07-18
2024-07-15
Brief Summary
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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).
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Detailed Description
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Cases (N = 1867) will be selected by the occurrence of the first atherosclerotic cardiovascular event (Acute Myocardial Infarction, Stroke and Peripheral Arterial Thrombotic-Ischemic Events) during the hospitalization phase for the management of the acute atherothrombotic event. The ratio between cases and controls will be 1:1. 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 definitions of acute atherothrombotic events follow classic clinical and complementary exam criteria and are based on national and international guidelines. The complete project was submitted to the local Institutional Review Board (IRB)/National Research Ethics Commission (CONEP) system and has ethical approval (CAAE: 56482922.2.1001.0070). All cases and controls will be invited to participate and, if they agree, an Informed Consent Form will be obtained.
Investigators will assess exposures to traditional risk factors in combination with genomic data (polygenic risk score) in both cases and controls, and these exposures will be expressed as odds ratios. Multiple logistic regression models will be built to adjust and determine the strengths of association between demographic variables, traditional risk factors and genetic data: gender, age, ethnicity, weight, body mass index, smoking, diabetes, hypertension, obesity, anxiety and depression, inadequate diet, physical inactivity, alcohol consumption and apolipoprotein B/A1 ratio (ApoB/ApoA1). For each association variable with a greater chance of cardiovascular disease (significant OR), an attributable risk will be calculated to estimate the fraction of risk attributable to the genetic component (Polygenic Risk Score) and to other clinical and demographic variables.
The polygenic risk score will be calculated through a hybrid approach by taking into account the following features: effect size of each Single Nucleotide Polymorphism (SNP), number of effect alleles observed, sample ploidy, total number of SNPs included in the Polygenic Risk Score, and the number of nonmissing SNPs in the sample. Each risk allele will be given points in the risk score, and the total score will range between 0 (absence of risk alleles) and the maximum value (yet to be defined), based on the distribution of risk alleles that will be identified in the population included in the study. The scale will be interpreted in a direct (positive) association, i.e., the higher the score, the higher the number of alleles and respective weighted effect sizes. Finally, the polygenic risk score will be adjusted to previously reported traditional risk factors for atherosclerotic cardiovascular disease to determine the attributable risk fraction associated with the genomic profile.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case - atherosclerotic cardiovascular disease
Patients with the first atherosclerotic cardiovascular event (Acute Myocardial Infarction, Stroke and Peripheral Artery Thrombotic-Ischemic Events)
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)
Control - without atherosclerotic cardiovascular disease ou healthy
Patients who sought medical care at the same site as cases without atherosclerotic cardiovascular event (Acute Myocardial Infarction, Stroke and Peripheral Artery Thrombotic-Ischemic Events) or healthy individuals
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patients already recruited in another study linked to the GENOMA Brazil Program.
18 Years
ALL
Yes
Sponsors
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Grupo Fleury
UNKNOWN
Ministry of Health, Brazil
OTHER_GOV
Hospital Alemão Oswaldo Cruz
OTHER
Responsible Party
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Álvaro Avezum Junior
Principal Investigator
Principal Investigators
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Álvaro Avezum, MD, PhD
Role: STUDY_CHAIR
Hospital Alemão Oswaldo Cruz
Locations
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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
Countries
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Other Identifiers
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CAAE: 56482922.2.1001.0070
Identifier Type: OTHER
Identifier Source: secondary_id
HAlemaoOswaldoCruz
Identifier Type: -
Identifier Source: org_study_id
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