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OpenTrials
Completed

NCT Number: NCT03243968

Endothelial and Microvascular Functions in Patients With Myocardial Ischemia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. %Hyper

    Time frame: One year

    Increment of forearm blood flow during reactive hyperemia after 5 minutes arm ischemia with venous occlusion plethysmography.

Secondary outcomes

  1. Intercellular adhesion molecule (ICAM)

    Time frame: One year

    Inflammatory biomarker obtained through withdrawal of venous blood.

  2. Vascular adhesion molecule (VCAM)

    Time frame: One year

    Inflammatory biomarker obtained through withdrawal of venous blood.

  3. Adiponectin

    Time frame: One year

    Adipokyne obtained through withdrawal of venous blood.

  4. Endothelin

    Time frame: One year

    Potent vasoconstrictor obtained through withdrawal of venous blood.

  5. LDL-oxidized

    Time frame: One year

    Low density lipoprotein oxidized used to measure oxidative stress. It is obtained from venous blood.

  6. CRP

    Time frame: One year

    C reactive protein obtained through withdrawal of venous blood.

  7. % Nitro

    Time frame: One year

    Increment of forearm blood flow after 5 minutes of 400 μg sublingual nitroglycerin application with venous occlusion plethysmography..

  8. FCD

    Time frame: One year

    Functional capillary density. Number of capillaries with flowing red blood cell in microscope area. Obtained from Nailfold videocapillaroscopy.

  9. AFCD

    Time frame: One year

    Afferent capillar diameter. Obtained from Nailfold videocapillaroscopy.

  10. ACD

    Time frame: One year

    Apical capillar diameter. Obtained from Nailfold videocapillaroscopy.

  11. EFCD

    Time frame: One year

    Efferent capillar diameter. Obtained from Nailfold videocapillaroscopy.

  12. RBCV

    Time frame: One year

    Basal red blood cell velocity. Obtained from Nailfold videocapillaroscopy.

  13. RBCVmax

    Time frame: One year

    Maximum red blood cell velocity during reactive hyperemia in fourth finger after one minute ischemia. Obtained from Nailfold videocapillaroscopy.

  14. TRBCVmax

    Time frame: One year

    Time to reach Maximum red blood cell velocity during reactive hyperemia in fourth finger after one minute ischemia. Obtained from Nailfold videocapillaroscopy.

  15. %ResHyper

    Time frame: One year

    Increment of vascular resistance during reactive hyperemia after 5 minutes arm ischemia with venous occlusion plethysmography.

  16. %ResNitro

    Time frame: One year

    Increment of vascular resistance after 5 minutes of 400 μg sublingual nitroglycerin application with venous occlusion plethysmography.

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Collaborators

  • Camillo L.C. Junqueira
  • Eliete Bouskela
  • Esmeralci Ferreira
  • Maria das Graças C. Souza

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 9, 2017
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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