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

NCT03583047 | Completed DMC

• 1 other identifier: CONS0008-2014-1
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction; Cardiovascular Risk Factor; Coronary Syndrome, Acute

Keywords

MACE; EPCs; Cardiovascular risk; Endothelial dysfunction; Prognosis

Outcome Measures

Primary Outcomes (1)

• Development of any Major Adverse Cardiovascular Event (MACE)

  Development of any MACE (a combination of major cardiovascular events, including death, heart failure, post-infarction angina, or new myocardial infarction) during a 3 months follow-up after angioplasty and stent placement.

  3 months

Secondary Outcomes (1)

• Development of any Major Adverse Cardiovascular Event (MACE)

  6 months

Eligibility Criteria

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

Study Population

* Ischemic patients who are submitted to a percutaneous coronary intervention. * Atherosclerotic patients with coronary stent. * All the patients included are from the hospital "20 de noviembre, ISSSTE" in Mexico City.

You may qualify if:

• Coronary syndrome patients
• Patients with Endothelial dysfunction

Sponsors & Collaborators

• Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado: lead
• National Council of Science and Technology, Mexico: collaborator

Study Sites (1)

National Medical Center "20 de Noviembre", ISSSTE

Mexico City, 03100, Mexico

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

total blood blood serum, and blood plasma

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Juan A. Suárez-Cuenca, Ph.D

  Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 11, 2018
• Study Start: January 15, 2016
• Primary Completion: October 10, 2019
• Study Completion: October 15, 2019
• Last Updated: March 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)