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Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction

NCT02021760 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-02-09

No results posted yet for this study

Summary

* Trial objective: To test the hypothesis that remote per-postconditioning in connection with primary PCI will reduce myocardial infarct size patients with STEMI.
* Trial Design: Placebo controlled randomized study with parallel groups
* Primary Endpoint: Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance (CMR) day 4-7
* Efficacy Parameters: Myocardial infarct size expressed as a percentage to the myocardium at risk determined by CMR at 6 months.
* Global left ventricular function determined by left ventricular ejection fraction determined by CMR.
* Microvascular obstruction determined by CMR day 4-7. Quantified ECV (extracellular volume) in left ventricular as myocardium at risk day 4-7 and remodelling parameters day 180.
* Safety Parameters: Major adverse cardiovascular events.

Conditions

Interventions

PROCEDURE

Primary Percutaneous Coronary Intervention

Primary Percutanous Coronary Intervention is performed in both Groups.

Sponsors & Collaborators

  • John Pernow

    lead OTHER

Principal Investigators

  • John Pernow, Professor · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-05-31
Completion
2015-11-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT02021760 on ClinicalTrials.gov