Implications of the Presence of Non-obstructive Atherosclerotic Plaques on Platelet and Vascular Reactivity

NCT03632785 | Completed

• 1 other identifier: FAPESP 2014/01021-4 - Subp. 1
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 50% of coronary events occur in previously asymptomatic patients. Thus, the early detection of the individuals at higher risk became an important research target within the current cardiology. The various clinical scores used present a predictive accuracy for ischemic events, evaluated by the ROC curve, which ranges from 0.73 to 0, 79. Therefore, the introduction of new non-invasive techniques for the detection of atherosclerosis aims to allow a more adequate classification of risk. The development of radiological techniques, fundamentally coronary angiotomography of multiple detectors (CAMD) and electron beam computed tomography-EBCT‖, demonstrated that the degree of coronary calcification correlates with endothelial lesion and individual prognosis in the long term. Notably, the calcium score has a weak correlation with the severity of coronary stenosis per se, possibly due to variations in arterial remodeling due to coronary calcification. On the other hand, the CAMD allows the detection of a small magnitude atheromatous disease, not diagnosed clinically, nor by tests provoking ischemia, or even by coronary catheterization. The clinical relevance of the small magnitude atheromatous disease diagnosed by the ACMD and its correlation with plaque vulnerability markers, mainly platelet aggregation, vascular reactivity, and inflammation are still not well determined. This is a case and control study and we will enrolled 90 patients with low and medium risk of cardiovascular event whose cases should present discrete plaques in the CAMD e controls should present none plaque in coronary stenosis Coronary atherosclerotic disease often begins in the transition from childhood to adolescence, progressing slowly and quietly. Its clinical manifestation occurs in the majority of cases from the 4th decade of life. However, it is important to remember that necropsy studies conducted in the 1970s identified the presence of non-obstructive atherosclerotic plaques in the aorta of individuals from the second decade of life. From its first description to the present day, the subject has been deeply studied, providing reliable information on several mechanisms involved in atherogenesis, disease progression and plaque unstabilization, which may occur in a silent manner or lead to a clinical picture of unstable myocardial ischemic syndrome (UMIS). In this period, classic risk factors for coronary artery disease (age, sex, diabetes mellitus, systemic arterial hypertension, hypercholesterolemia and smoking, among others) were described, and risk scores were developed that aid in the individual prediction of the probability of disease manifestation coronary artery disease (CAD). The most widespread of these scores is that developed from the population of Framingham, which was started in the United States of the same name after 1948. Subjects with no evidence of cardiovascular disease were followed prospectively with biannual evaluations. The data obtained allowed the elaboration of an algorithm of prediction of individual risk that is included in the most recent recommendations of evaluation of cardiovascular risk. However, these traditional clinical assessment scores tend to underestimate cardiovascular risk in some populations, especially in women and young individuals. In the global population, the various clinical scores used have a predictive accuracy for ischemic events, as assessed by the ROC (Receiver Operating Characteristic) curve, ranging from 0.73 to 0.79. In this way, the concept of "detection interval" is proposed. Defined by the difference between cases of coronary disease or cardiovascular events detected and the actual total prevalence of atherosclerotic disease in the population, such detection interval opens a new field for the introduction of new non-invasive atherosclerosis investigation techniques. Taking into account that approximately 50% of coronary events occur in previously asymptomatic patients, the early detection of these individuals at greater risk has become an important research target within the current cardiology. More recently, the development of radiologic techniques, fundamentally coronary angiography of multiple detectors (CAMD) and electron beam computed tomography (EBCT), have demonstrated that the degree of coronary calcification correlates with endothelial lesion and individual prognosis in the long term, allowing to refine the clinical classification of a patient's risk for a greater or lesser chance of fatal and non-fatal events. Notably, the calcium score has a weak correlation with the severity of coronary stenosis per se, possibly due to variations in the arterial remodeling due to coronary calcification. On the other hand, calcification of the coronary arteries is known to be associated with lower myocardial blood flow even in the absence of significant stenosis. This means that calcification is not merely a marker of obstructive coronary disease and may predispos

Conditions

Coronary Angiography of Multiple Detectors; Platelet Aggregation, Spontaneous; Cardiovascular Risk Factor; Discrete Coronary Artery Stenosis

Keywords

Platelet; Coronary stenosis; Coronary angiography

Outcome Measures

Primary Outcomes (1)

• Platelet aggregation by VerifyNow System - P2Y12®

  Comparing platelet aggregation by VerifyNow System - P2Y12® (An equipment from Accriva Diagnostics that evaluates platelet aggregation) in case and control groups.

  1 day

Secondary Outcomes (4)

• Platelet aggregation by Multiplate-ADP®, Multiplate-ASPI®

  1day

• Endothelial function

  1 day

• Platelet-reticulated

  1day

• Inflammatory activity

  1day

Other Outcomes (5)

• Genetic polymorphisms

  1day

• Transport of lipids to HDL

  1 day

• Correlate results

  through study completion, an average of 1 year

Eligibility Criteria

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

Study Population

Patients older than 18 years, male and female with low and medium risk of cardiovascular disease without atherosclerotic disease manifest.

You may qualify if:

• Low or Medium Risk of cardiovascular disease assessed by the Framingham criteria;
• That agrees to sign the Consent Form;
• Absence of known atherosclerotic disease;
• Patients in the case group should additionally present discrete plaques (s) evaluated by coronary angiotomography of multiple detectors (CAMD). Patients in the control group should be absent from any coronary atherosclerotic process to CAMD.

You may not qualify if:

• Known atherosclerotic disease manifest;
• Previous acute coronary syndrome (ACS);
• Use of antiplatelet agents and / or anticoagulants;
• Use of NSAIDs and/or corticosteroids
• Known platelet dysfunction or platelets \<100,000 / μL or\> 450,000 / μL
• Hematocrit \<33% and \> 52%
• Hematological diseases;
• Liver disease;
• Known malignant neoplasm;
• Refusal to sign free and informed consent.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

José Carlos Nicolau

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Publications (22)

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Biospecimen

Retention: SAMPLES WITH DNA

whole blood, plasma

MeSH Terms

Conditions

Platelet Aggregation, Spontaneous; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD.

Study Record Dates

• First Submitted: August 5, 2018
• First Posted: August 15, 2018
• Study Start: March 27, 2017
• Primary Completion: September 30, 2019
• Study Completion: December 10, 2019
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)