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

Endothelial Dysfunction Clinical Trial

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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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583047
• Other study ID #: CONS0008-2014-1
• Status: Completed
• Start date: January 15, 2016
• Est. completion date: October 15, 2019

Study information

• Verified date: March 2021
• Source: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 15, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Coronary syndrome patients
• Patients with Endothelial dysfunction Exclusion Criteria: -

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiovascular Risk Factor
• Coronary Syndrome, Acute
• Endothelial Dysfunction
• Syndrome

Locations

Country	Name	City	State
Mexico	National Medical Center "20 de Noviembre", ISSSTE	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado	National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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