Intracoronary Features in the Prognosis of Endothelial Dysfunction and MACES in Population With Acute Coronary Syndrome

NCT ID: NCT03583047

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-15
• Study Completion Date: 2019-10-15

Brief Summary

Coronary Artery Disease (CAD) is common in Mexico, while morbidity and mortality is high. Drug therapy can relieve angina pain and stabilize plaque, but it is not able to re-flow a coronary artery. Balloon angioplasty and/or stent placement, re-establishes coronary blood flow; however, the risk of re-stenosis and/or development of new coronary events remains latent. Endothelial damage, reflected by the degree of endothelial dysfunction, inflammation and oxidative stress, promotes atherogenesis, which plays a central role in the pathophysiology of CAD. These mechanisms have been studied in animal models; however, it is widely unknown whether it influences the coronary circulation in humans. Therefore the present study explores the impact of an intracoronary profile of biomarkers of endothelial dysfunction, inflammation and oxidative stress on the prognosis of coronary remodeling and new adverse cardiovascular events in patients with chronic stable coronary syndrome undergoing angioplasty and stent placement.

Detailed Description

Study design: Observational, longitudinal, analytic and prospective cohort study.

.With the Ethics and institutional investigation Committee acceptance, patients with stable coronary plaque or post-infarct angina with indicated coronary angiography and stent placement, from the Hemodynamic Unit from the National Medical Center "20 de Noviembre" of the Institute of Security and Social Services of State Workers (ISSSTE) are invited to participate. Patients who agree to participate in the study sign the informed consent. The independent variables will be the coronary profile components (oxidative stress, inflammation and endothelial disfunction biomarkers) and the consequence variables (dependent) will be the coronary and/or stent remodeling during the post-angioplasty with stent placement monitoring, Major Adverse Cardiovascular Events (MACE) during the post-angioplasty with stent placement monitoring period.

Clinical data:

to homogenize the study population respect to potentially confusing variables, information about sex, age, body mass index, vital signs. lipid profile. co-morbility presence like systemic arterial hypertension, diabetes mellitus, metabolic syndrome, drugs and troponin determination for stratify the acute coronaropathy.

Coronary Catheterization and sampling. The coronary catheterization (angioplasty with stent placement) is made under medical indication.

-Coronary catheterism: Is made in the hemodynamic laboratory. Asepsis, antisepsis and local anesthesia are performed in the intravascular approach area.

Conditions

Endothelial Dysfunction; Cardiovascular Risk Factor; Coronary Syndrome, Acute

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Coronary syndrome patients
• Patients with Endothelial dysfunction

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Council of Science and Technology, Mexico

OTHER

Sponsor Role: collaborator

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

OTHER_GOV

Sponsor Role: lead

Responsible Party

Juan Antonio Suárez Cuenca

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan A. Suárez-Cuenca, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Locations

National Medical Center "20 de Noviembre", ISSSTE

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

CONS0008-2014-1

Identifier Type: -

Identifier Source: org_study_id