NCT03243968

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

1.5 years

First QC Date

August 2, 2017

Last Update Submit

August 4, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • %Hyper

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

    One year

Secondary Outcomes (16)

  • Intercellular adhesion molecule (ICAM)

    One year

  • Vascular adhesion molecule (VCAM)

    One year

  • Adiponectin

    One year

  • Endothelin

    One year

  • LDL-oxidized

    One year

  • +11 more secondary outcomes

Study Arms (2)

Ischemic patient - IP

25 participants with myocardial ischemia detected by scintigraphy and normal coronarography

Control group - CG

25 healthy non-ischemic individuals

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD and PHD

Study Record Dates

First Submitted

August 2, 2017

First Posted

August 9, 2017

Study Start

March 1, 2014

Primary Completion

August 30, 2015

Study Completion

August 30, 2015

Last Updated

August 9, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share