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The Acute and Chronic Effects of Remote Ischemic Conditioning on Cardiovascular Function

NCT03984123 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2020-05-04

No results posted yet for this study

Summary

The investigators are going to examine 270 patients within 48h of STEMI with primary percutaneuous intervention. The investigators utilise either a double -with a 15- min intervening interval-, or a single ischemic stimulus by brachial cuff inflation of both arms at 200mmHg for 5 min to cause remote conditioning (RIC) or no cuff inflation. Each ischemic stimulus is followed by a vascular function assessment, with a final assessment 25 minutes after the second cuff deflation. All patients utilising a cuff inflation procedure also undergo a sham cuff inflation. The investigators measure: a) the perfusion boundary region (PBR-micrometers) of the sublingual arterial microvessels as a marker of endothelial glycocalyx thickness to assess vascular permeability, b) the carotid-femoral pulse wave velocity (PWV). At baseline (T0) and the last vascular assessment (T3) The researchers also measure microRNA-144,-150,-499 (cardioprotective action), -21, and -208 (remodeling stimuli) expression, nitrate- nitrite (NOx) and malondialdehyde (MDA) plasma levels. Moreover, the investigators are going to perform an echocardiographic study at 1 and 2 years after the recruitment to investigate whether the left ventricular function differs among the 3 study arms (2 RIC protocols and no intervention)

Conditions

  • Acute Myocardial Infarction

Interventions

DEVICE

Brachial cuff, in order to achieve ischemic stimuli

Standard treatment with no brachial cuff inflation

Sponsors & Collaborators

  • University of Athens

    lead OTHER

Principal Investigators

  • Dimitrios Vlastos, MD · 2nd Cardiology Department, University of Athens, Greece

  • Efstathios K. Iliodromitis, MD, PhD · 2nd Cardiology Department, University of Athens, Greece

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-27
Primary Completion
2020-07-10
Completion
2020-11-18

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03984123 on ClinicalTrials.gov