Endothelial and Microvascular Functions in Patients With Myocardial Ischemia

Evaluation of Endothelial and Microvascular Functions in Patients With Myocardial Ischemia Detected by Scintilography and Normal Coronariography

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.

Study Overview

• Status: Completed
• Conditions: Microcirculation; Biomarkers; Myocardial Ischemia

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 Type: Observational
• Enrollment (Actual): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Fifty patients were studied: 39% male and 61% female. The mean age was 48 ± 15.8 years, being: 56.5 ± 10.5 years in the IP group and 39.4 ± 15.8 years in the CG. The mean BMI was 26.5 ± 4.30 kg/m².

Description

Inclusion Criteria:

The study population consisted of 50 patients of both sexes, stratified into two groups: patients with myocardial ischemia detected by scintigraphy (group IP, n = 25) and healthy individuals (CG group, n = 25). In the patients who underwent scintigraphy with tomographic sections and presented any type of image attenuation during the examination, they also underwent a complementary prone position technique. Patients without these characteristics scintigraphy methodologies were excluded from the study.

Exclusion Criteria:

Exclusion criteria were adopted: patients with type 1 or 2 Diabetes Mellitus, heart failure, myocardial infarction or brain stroke with less than three months of the event, chronic renal disease, users of hormonal or non-hormonal anti-inflammatory drugs, recent trauma (less than three months) autoimmune diseases, active infectious processes, presence of neoplasia, use of Aspirin (anti-inflammatory dose), obesity with BMI>35 kg/m², uncontrolled hypertensive patients, resistant hypertensives, and non-compliance in the examinations or with the signature of the Consent Form.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Ischemic patient - IP; 25 participants with myocardial ischemia detected by scintigraphy and normal coronarography
Control group - CG; 25 healthy non-ischemic individuals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
%Hyper	Increment of forearm blood flow during reactive hyperemia after 5 minutes arm ischemia with venous occlusion plethysmography.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intercellular adhesion molecule (ICAM)	Inflammatory biomarker obtained through withdrawal of venous blood.	One year
Vascular adhesion molecule (VCAM)	Inflammatory biomarker obtained through withdrawal of venous blood.	One year
Adiponectin	Adipokyne obtained through withdrawal of venous blood.	One year
Endothelin	Potent vasoconstrictor obtained through withdrawal of venous blood.	One year
LDL-oxidized	Low density lipoprotein oxidized used to measure oxidative stress. It is obtained from venous blood.	One year
CRP	C reactive protein obtained through withdrawal of venous blood.	One year
% Nitro	Increment of forearm blood flow after 5 minutes of 400 μg sublingual nitroglycerin application with venous occlusion plethysmography..	One year
FCD	Functional capillary density. Number of capillaries with flowing red blood cell in microscope area. Obtained from Nailfold videocapillaroscopy.	One year
AFCD	Afferent capillar diameter. Obtained from Nailfold videocapillaroscopy.	One year
ACD	Apical capillar diameter. Obtained from Nailfold videocapillaroscopy.	One year
EFCD	Efferent capillar diameter. Obtained from Nailfold videocapillaroscopy.	One year
RBCV	Basal red blood cell velocity. Obtained from Nailfold videocapillaroscopy.	One year
RBCVmax	Maximum red blood cell velocity during reactive hyperemia in fourth finger after one minute ischemia. Obtained from Nailfold videocapillaroscopy.	One year
TRBCVmax	Time to reach Maximum red blood cell velocity during reactive hyperemia in fourth finger after one minute ischemia. Obtained from Nailfold videocapillaroscopy.	One year
%ResHyper	Increment of vascular resistance during reactive hyperemia after 5 minutes arm ischemia with venous occlusion plethysmography.	One year
%ResNitro	Increment of vascular resistance after 5 minutes of 400 μg sublingual nitroglycerin application with venous occlusion plethysmography.	One year

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University
• Collaborators: Eliete Bouskela; Camillo L.C. Junqueira; Esmeralci Ferreira; Maria das Graças C. Souza

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): August 30, 2015
• Study Completion (Actual): August 30, 2015

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 4, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: Biovasc isquêmicos

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No