Microcirculation; Biomarkers; Myocardial Ischemia Clinical Trial
Official title:
Evaluation of Endothelial and Microvascular Functions in Patients With Myocardial Ischemia Detected by Scintilography and Normal Coronariography
| Verified date | August 2017 |
| Source | Rio de Janeiro State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | August 30, 2015 |
| Est. primary completion date | August 30, 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Rio de Janeiro State University | Camillo L.C. Junqueira, Eliete Bouskela, Esmeralci Ferreira, Maria das Graças C. Souza |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | %Hyper | Increment of forearm blood flow during reactive hyperemia after 5 minutes arm ischemia with venous occlusion plethysmography. | One year | |
| Secondary | Intercellular adhesion molecule (ICAM) | Inflammatory biomarker obtained through withdrawal of venous blood. | One year | |
| Secondary | Vascular adhesion molecule (VCAM) | Inflammatory biomarker obtained through withdrawal of venous blood. | One year | |
| Secondary | Adiponectin | Adipokyne obtained through withdrawal of venous blood. | One year | |
| Secondary | Endothelin | Potent vasoconstrictor obtained through withdrawal of venous blood. | One year | |
| Secondary | LDL-oxidized | Low density lipoprotein oxidized used to measure oxidative stress. It is obtained from venous blood. | One year | |
| Secondary | CRP | C reactive protein obtained through withdrawal of venous blood. | One year | |
| Secondary | % Nitro | Increment of forearm blood flow after 5 minutes of 400 µg sublingual nitroglycerin application with venous occlusion plethysmography.. | One year | |
| Secondary | FCD | Functional capillary density. Number of capillaries with flowing red blood cell in microscope area. Obtained from Nailfold videocapillaroscopy. | One year | |
| Secondary | AFCD | Afferent capillar diameter. Obtained from Nailfold videocapillaroscopy. | One year | |
| Secondary | ACD | Apical capillar diameter. Obtained from Nailfold videocapillaroscopy. | One year | |
| Secondary | EFCD | Efferent capillar diameter. Obtained from Nailfold videocapillaroscopy. | One year | |
| Secondary | RBCV | Basal red blood cell velocity. Obtained from Nailfold videocapillaroscopy. | One year | |
| Secondary | RBCVmax | Maximum red blood cell velocity during reactive hyperemia in fourth finger after one minute ischemia. Obtained from Nailfold videocapillaroscopy. | One year | |
| Secondary | 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 | |
| Secondary | %ResHyper | Increment of vascular resistance during reactive hyperemia after 5 minutes arm ischemia with venous occlusion plethysmography. | One year | |
| Secondary | %ResNitro | Increment of vascular resistance after 5 minutes of 400 µg sublingual nitroglycerin application with venous occlusion plethysmography. | One year |