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

Intracoronary Profile of Inflammation, Oxidative Stress and Endothelial Progenitor Cells (EPCs) in the Prognosis of Endothelial Dysfunction, Stent Re-stenosis and Cardiovascular Events in Population With Acute Coronary Syndrome.

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.

Study Overview

• Status: Completed
• Conditions: Endothelial Dysfunction; Cardiovascular Risk Factor; Coronary Syndrome, Acute

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.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 03100
    • National Medical Center "20 de Noviembre", ISSSTE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• Coronary syndrome patients
• Patients with Endothelial dysfunction

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of any Major Adverse Cardiovascular Event (MACE)	Development of any MACE (A combination of any major cardiovascular events, including death, heart failure, post-infarction angina or new myocardial infarction) during a 6 months follow up after angioplasty and stent placement	6 months

Collaborators and Investigators

• Sponsor: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
• Collaborators: National Council of Science and Technology, Mexico
• Investigators: Principal Investigator: Juan A. Suárez-Cuenca, Ph.D, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2016
• Primary Completion (ACTUAL): October 10, 2019
• Study Completion (ACTUAL): October 15, 2019

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (ACTUAL): July 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Endothelial dysfunction; Prognosis; Cardiovascular risk; MACE; EPCs
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: CONS0008-2014-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO