Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-02-25 @ 2:31 AM
Study NCT ID:
NCT03243968
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2017-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endothelial and Microvascular Functions in Patients With Myocardial Ischemia
Sponsor:
Rio de Janeiro State University
Organization:
Study Overview
Official Title:
Evaluation of Endothelial and Microvascular Functions in Patients With Myocardial Ischemia Detected by Scintilography and Normal Coronariography
Status:
COMPLETED
Status Verified Date:
2017-08
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:
None
Brief Summary:
Cardiovascular diseases (CVD) are responsible, throughout the world, for high mortality rates and cardiovascular morbidity. Endothelial dysfunction is the earliest marker of clinical atherosclerosis development. Human studies show that endothelial and microvascular dysfunction are independent predictors of ischemic cardiovascular events and long-term prognosis. The study´s objective is to evaluate the endothelial and peripheral microcirculation changes by venous occlusion plethysmography (VOP), nailfoldvideocapillaroscopy (NVC) and serum biomarkers in patients with myocardial ischemia detected by scintigraphy and normal coronarography.
Detailed Description:
A cross-sectional study was carried out with 50 participants: 25 with myocardial ischemia detected by scintigraphy and normal coronarography (Ischemic Patient - IP) and 25 healthy non-ischemic individuals (Control Group - CG). All of them were submitted to anamnesis, serum markers (Intercellular Cell Adhesion Molecule \[ICAM\], Vascular Cell Adhesion Molecule\[VCAM\], adiponectin, endothelin, LDL-oxidized and CRP-US), NVC and VOP. Exclusion criteria were: inflammatory diseases, cancer patients, recent traumas, Diabetes Mellitus, obese individuals with BMI\> 35 kg/m², uncontrolled hypertensive patients, and those with active infectious processes. In the NVC,capillary diameters were observed, as well as red blood cells velocity in the capillaries (RBCV, mm/s), maximum red blood cells after 1 minute ischemia (RBCVmax, mm/s) and time to reach maximal velocity (TRBCVmax) and, regarding VOP,the baseline blood flow (ml/min), post 5 minute ischemia flow and vascular resistance (mmHg/ml/min) were evaluated. Data were analyzed using Student's t-tests for independent or Mann-Whitney samples; χ2 or Fisher exact. The absolute and relative variations (delta) of plethysmography measurements versus baseline in each group were analyzed by the Wilcoxon signed-ranks test and compared between the groups by the Mann-Whitney test. For correction of confounding factors, age and BMI, it was used Covariance Analysis (ANCOVA).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: