Brazilian Coronary ARtery Disease

NCT05392491 | Completed

• 1 other identifier: BARD Study
• Study Type: observational
• Target: 4,004
• Locations: 1 country
• Sites: 1

Brief Summary

Although coronary artery disease may have a stable chronic clinical course, it is known that this reality does not apply to atherosclerotic plaques, they can grow, complicate, stabilize and again start new cycles of growth/destabilization/stabilization or quiescence in the presence or absence of symptoms. While in obstructive coronary lesions there are well-founded guidelines based on multiple clinical studies, in relation to investigation and treatment; on the other hand, in non-obstructive lesions, there are no such guidelines. There are gaps in the knowledge about the prognostic implications of minor injuries and the occurrence of events. This study seeks precisely to fill these knowledge gaps. Of particular relevance are the large number of patients (approximately 10,000 patients) and the long clinical follow-up, that is, in eight years.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Outcomes; Cohort

Outcome Measures

Primary Outcomes (1)

• Number of participants with Composite Outcome

  Participants presenting the following outcomes: death of any cause, acute myocardial infarction, stroke, and need for revascularization.

  8 years

Secondary Outcomes (3)

• Number of participants with acute myocardial infarction

  8 years

• Number of participants with stroke

  8 years

• Number of participants needing revascularization

  8 years

Study Arms (3)

Control group (without coronary lesions)

Cohort control group. No interventions.

Other: No intervention

Coronary Lesion < 30%

Participants with coronary lesion under 30%. No interventions.

Other: No intervention

Coronary Lesion > 30% and < 50%

Participants with coronary lesions greater than 30% and under 50%. No interventions.

Other: No intervention

Interventions

No intervention OTHER

No intervention. It is an observational study

Control group (without coronary lesions); Coronary Lesion < 30%; Coronary Lesion > 30% and < 50%

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to Instituto do Coração (InCor HC, FM-USP) for invasive coronary angiography or angiotomography, for diagnosis of coronary heart disease from January 1, 2011 to December 31, 2017.

You may qualify if:

• Patients referred to Instituto do Coração (InCor HC, FM-USP) for invasive coronary angiography or angiotomography.

You may not qualify if:

• Age under 18 years or over 80 years at the time of examination;
• Previous history of acute coronary syndrome (infarction and unstable angina);
• Revascularization interventions (surgical or percutaneous);
• Valvular heart disease;
• Cardiomyopathies;
• Diseases with a poor prognosis (expected survival of less than 8 years).

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração InCor, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (10)

• Makarovic Z, Makarovic S, Bilic-Curcic I, Mihaljevic I, Mlinarevic D. NONOBSTRUCTIVE CORONARY ARTERY DISEASE - CLINICAL RELEVANCE, DIAGNOSIS, MANAGEMENT AND PROPOSAL OF NEW PATHOPHYSIOLOGICAL CLASSIFICATION. Acta Clin Croat. 2018 Sep;57(3):528-541. doi: 10.20471/acc.2018.57.03.17.

  PMID: 31168187 BACKGROUND

• Maddox TM, Stanislawski MA, Grunwald GK, Bradley SM, Ho PM, Tsai TT, Patel MR, Sandhu A, Valle J, Magid DJ, Leon B, Bhatt DL, Fihn SD, Rumsfeld JS. Nonobstructive coronary artery disease and risk of myocardial infarction. JAMA. 2014 Nov 5;312(17):1754-63. doi: 10.1001/jama.2014.14681.

  PMID: 25369489 BACKGROUND

• Bech GJ, De Bruyne B, Pijls NH, de Muinck ED, Hoorntje JC, Escaned J, Stella PR, Boersma E, Bartunek J, Koolen JJ, Wijns W. Fractional flow reserve to determine the appropriateness of angioplasty in moderate coronary stenosis: a randomized trial. Circulation. 2001 Jun 19;103(24):2928-34. doi: 10.1161/01.cir.103.24.2928.

  PMID: 11413082 BACKGROUND

• Ahmadi A, Argulian E, Leipsic J, Newby DE, Narula J. From Subclinical Atherosclerosis to Plaque Progression and Acute Coronary Events: JACC State-of-the-Art Review. J Am Coll Cardiol. 2019 Sep 24;74(12):1608-1617. doi: 10.1016/j.jacc.2019.08.012.

  PMID: 31537271 BACKGROUND

• McClelland RL, Jorgensen NW, Budoff M, Blaha MJ, Post WS, Kronmal RA, Bild DE, Shea S, Liu K, Watson KE, Folsom AR, Khera A, Ayers C, Mahabadi AA, Lehmann N, Jockel KH, Moebus S, Carr JJ, Erbel R, Burke GL. 10-Year Coronary Heart Disease Risk Prediction Using Coronary Artery Calcium and Traditional Risk Factors: Derivation in the MESA (Multi-Ethnic Study of Atherosclerosis) With Validation in the HNR (Heinz Nixdorf Recall) Study and the DHS (Dallas Heart Study). J Am Coll Cardiol. 2015 Oct 13;66(15):1643-53. doi: 10.1016/j.jacc.2015.08.035.

  PMID: 26449133 BACKGROUND

• Fernandez-Friera L, Penalvo JL, Fernandez-Ortiz A, Ibanez B, Lopez-Melgar B, Laclaustra M, Oliva B, Mocoroa A, Mendiguren J, Martinez de Vega V, Garcia L, Molina J, Sanchez-Gonzalez J, Guzman G, Alonso-Farto JC, Guallar E, Civeira F, Sillesen H, Pocock S, Ordovas JM, Sanz G, Jimenez-Borreguero LJ, Fuster V. Prevalence, Vascular Distribution, and Multiterritorial Extent of Subclinical Atherosclerosis in a Middle-Aged Cohort: The PESA (Progression of Early Subclinical Atherosclerosis) Study. Circulation. 2015 Jun 16;131(24):2104-13. doi: 10.1161/CIRCULATIONAHA.114.014310. Epub 2015 Apr 16.

  PMID: 25882487 BACKGROUND

• Ostgren CJ, Soderberg S, Festin K, Angeras O, Bergstrom G, Blomberg A, Brandberg J, Cederlund K, Eliasson M, Engstrom G, Erlinge D, Fagman E, Hagstrom E, Lind L, Mannila M, Nilsson U, Oldgren J, Ostenfeld E, Persson A, Persson J, Persson M, Rosengren A, Sundstrom J, Swahn E, Engvall JE, Jernberg T. Systematic Coronary Risk Evaluation estimated risk and prevalent subclinical atherosclerosis in coronary and carotid arteries: A population-based cohort analysis from the Swedish Cardiopulmonary Bioimage Study. Eur J Prev Cardiol. 2021 Apr 23;28(3):250-259. doi: 10.1177/2047487320909300. Epub 2020 Mar 3.

  PMID: 33891684 BACKGROUND

• Gorgulho B, Alves MA, Teixeira JA, Santos RO, de Matos SA, Bittencourt MS, Bensenor I, Lotufo P, Marchioni DM. Dietary patterns associated with subclinical atherosclerosis: a cross-sectional analysis of the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil) study. Public Health Nutr. 2021 Oct;24(15):5006-5014. doi: 10.1017/S1368980020005340. Epub 2021 Jan 8.

  PMID: 33413712 BACKGROUND

• Miname MH, Bittencourt MS, Moraes SR, Alves RIM, Silva PRS, Jannes CE, Pereira AC, Krieger JE, Nasir K, Santos RD. Coronary Artery Calcium and Cardiovascular Events in Patients With Familial Hypercholesterolemia Receiving Standard Lipid-Lowering Therapy. JACC Cardiovasc Imaging. 2019 Sep;12(9):1797-1804. doi: 10.1016/j.jcmg.2018.09.019. Epub 2018 Nov 15.

  PMID: 30448145 BACKGROUND

• Pagidipati NJ, Peterson ED. Should Cardiovascular Preventive Therapy Be Over-the-Counter? J Am Coll Cardiol. 2021 Sep 14;78(11):1124-1126. doi: 10.1016/j.jacc.2021.07.020. No abstract available.

  PMID: 34503681 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Protasio Luz, PhD

  Instituto do Coração InCor, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 26, 2022
• Study Start: June 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 4, 2025

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)