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

NCT05515653 | Active Not Recruiting

• 2 other identifiers: HAlemaoOswaldoCruzCAAE: 56482922.2.1001.0070
• Study Type: observational
• Target: 3,974
• Locations: 1 country
• Sites: 41

Brief 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).

Conditions

Cardiovascular Diseases; Acute MI; Stroke; Peripheral Arterial Disease; Genetic Predisposition to Disease

Keywords

case-control study; Polymorphism genetic; cardiovascular disease; observational study

Outcome Measures

Primary Outcomes (2)

• 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).

  Population attributable risk fraction of atherosclerotic cardiovascular diseases adjusted for other risk factors related to: diet, physical exercise, smoking, alcoholism, chronic disease history (diabetes, hypertension, dyslipidemia, etc) and biochemical parameters.

  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

  As it is a case-control study, there will be no follow-up for the occurrence of clinical events. Therefore, we will assess exposures to traditional risk factors to cardiovascular events (MI, Stroke and acute peripheral atherothrombotic event) 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

  through study completion, an average of 1 year

Study Arms (2)

Case - atherosclerotic cardiovascular disease

Patients with the first atherosclerotic cardiovascular event (Acute Myocardial Infarction, Stroke and Peripheral Artery Thrombotic-Ischemic Events)

Genetic: Exposure to genetics (polygenic)

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

Genetic: Exposure to genetics (polygenic)

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)

Also known as: polygenic risk score

Case - atherosclerotic cardiovascular disease; Control - without atherosclerotic cardiovascular disease ou healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In-hospital patients with the first atherosclerotic event will be enrolled (Cases). Patients being attended in the same hospitals without cardiovascular events or without any overt disease will be the controls. The sample size calculation assumed a dominant inheritance pattern, within a non-matched case-control study design 1:1. A sample of 1867 cases and 1867 controls would have a statistical power of 90% to detect a genetic OR of 1.3, assuming an allelic frequency of 10%, considering an unpaired control 1:1 of the genetic factor. A prevalence of 10% of the disease in the target population was considered, an alpha significance level of 5%, bilateral hypothesis test.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Alemão Oswaldo Cruz: lead
• Grupo Fleury: collaborator
• Ministry of Health, Brazil: collaborator

Study Sites (41)

Acurácia Serviços Médicos

Rio Branco, Acre, Brazil

Location

Centro de Pesquisas Clínicas Dr. Marco Mota HCOR

Maceió, Alagoas, Brazil

Location

Centro de Pesquisa Clínica do Coração

Aracaju, Ceará, Brazil

Location

Hospital Maternidade São Vicente de Paulo

Barbalha, Ceará, Brazil

Location

Hospital Evangélico de Vila Velha

Vila Velha, Espírito Santo, Brazil

Location

Hospital Universitário Cassiano Antônio de Moraes

Vitória, Espírito Santo, Brazil

Location

Hospital e Clínica São Roque

Ipiaú, Estado de Bahia, Brazil

Location

Instituto Cárdio Pulmonar da Bahia

Salvador, Estado de Bahia, Brazil

Location

Universidade Federal de Goiás - UFG

Goiânia, Goiás, Brazil

Location

Hospital Universitário da Universidade Federal do Maranhão/HU/UFMA

São Luís, Maranhão, Brazil

Location

Hospital Universitário Maria Aparecida Pedrossian

Campo Grande, Mato Grosso do Sul, Brazil

Location

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Location

Santa Casa de Misericórdia de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Location

Hospital de Clínicas da Universidade Federal do Triângulo Mineiro

Uberaba, Minas Gerais, Brazil

Location

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

Cuiabá, Mount, Brazil

Location

Hospital e Maternidade Angelina Caron

Campina Grande do Sul, Paraná, Brazil

Location

Núcleo de Pesquisa Clínica S/S

Curitiba, Paraná, Brazil

Location

Real Hospital Português de Beneficência em Pernambuco

Recife, Pernambuco, Brazil

Location

Hospital Universitário da Universidade Federal do Piauí

Teresina, Piauí, Brazil

Location

Instituto Atena de Pesquisa Clínica

Natal, Rio Grande do Norte, Brazil

Location

Associação Dr. Bartholomeu Tacchini

Bento Gonçalves, Rio Grande do Sul, Brazil

Location

Associacao Hospitalar Beneficente Sao Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Location

Santa Casa de Misericórdia de Pelotas

Pelotas, Rio Grande do Sul, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Nossa Senhora Da Conceicao Sa

Porto Alegre, Rio Grande do Sul, Brazil

Location

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Universitário de Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Location

Maestri e Kormann Consultoria Medico Cientifica

Blumenau, Santa Catarina, Brazil

Location

H&W Cardiologia LTDA

Joinville, Santa Catarina, 89204-250, Brazil

Location

Hospital Cirurgia

Aracaju, Sergipe, Brazil

Location

Hospital Municipal de Barueri

Barueri, São Paulo, Brazil

Location

Instituto de Pesquisa Clínica de Campinas

Campinas, São Paulo, Brazil

Location

Scentryfar Pesquisa Clínica

Campinas, São Paulo, Brazil

Location

Hospital Carlos Fenando Malzoni

Matão, São Paulo, Brazil

Location

Braile Hospital Dia Ltda

São José do Rio Preto, São Paulo, Brazil

Location

Fundação Faculdade de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Location

Hospital Alemão Oswaldo Cruz

São Paulo, São Paulo, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

Location

Instituto de Cardiologia HCFMUSP

São Paulo, São Paulo, Brazil

Location

Instituto de Pesquisa GNDI

São Paulo, São Paulo, Brazil

Location

Hospital Santa Paula

São Paulo, Brazil

Location

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Biospecimen

Retention: SAMPLES WITH DNA

Total blood, Buffy Coat

MeSH Terms

Conditions

Cardiovascular Diseases; Stroke; Peripheral Arterial Disease; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Álvaro Avezum, MD, PhD

  Hospital Alemão Oswaldo Cruz

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 25, 2022
• Study Start: July 18, 2022
• Primary Completion: February 20, 2023
• Study Completion: July 15, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (41)