Clinical trial NCT03583047: Intracoronary Features in the Prognosis of Endothelial Dysfunction and MACES in Population With Acute Coronary Syndrome
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endothelial Dysfunction
Cardiovascular Risk Factor
Coronary Syndrome, Acute
Keywords: MACE
EPCs
Cardiovascular risk
Endothelial dysfunction
Prognosis
Lead sponsor: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Sponsor class: OTHER_GOV
Collaborators: name: National Council of Science and Technology, Mexico
First posted: 2018-07-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* Coronary syndrome patients
* Patients with Endothelial dysfunction

Exclusion Criteria:

-

Primary outcomes:
measure: Development of any Major Adverse Cardiovascular Event (MACE)
timeFrame: 3 months
Secondary outcomes:
measure: Development of any Major Adverse Cardiovascular Event (MACE)
timeFrame: 6 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Medical Center "20 de Noviembre", ISSSTE
Study officials:
affiliation: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
name: Juan A. Suárez-Cuenca, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: