Ignite Creation Date:
2024-05-06 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03583047
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2018-06-04
Brief Title:
Intracoronary Features in the Prognosis of Endothelial Dysfunction and MACES in Population With Acute Coronary Syndrome
Sponsor:
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Organization:
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iphoneSPACE
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 andor stent placement re-establishes coronary blood flow however the risk of re-stenosis andor 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None