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Ischemic Postconditioning on Microvascular Obstruction in Reperfused Myocardial Infarction

NCT01898546 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2013-07-12

No results posted yet for this study

Summary

Objectives. We will evaluate the effect of ischemic postconditioning (PCON) on microvascular obstruction (MVO) in patients with a first ST-segment elevation myocardial infarction (STEMI) treated with primary angioplasty.

Background. PCON appears as a potentially beneficial tool in STEMI. Its impact on MVO is unknown.

Methods. In a multicenter study, 132 patients with a first STEMI will be randomized to undergo primary angioplasty followed by PCON or primary angioplasty alone (non-PCON). MVO and infarct size (IS) will be quantified (% of left ventricular mass) in a core laboratory analyzing late enhancement cardiovascular magnetic resonance imaging.

Conditions

Interventions

PROCEDURE

Primary angioplasty

Primary angioplasty preceded by 300 mg aspirin plus 600 mg clopidogrel oral load doses. The radial approach and the use of thrombus aspiration catheters will be recommended. Stent will be implanted in all cases. Balloon pre-dilatation or direct stenting will be decided according to lesion characteristics.

PROCEDURE

Postconditioning

1 min after stent deployment, the angioplasty balloon will be re-inflated 4 times during 1 min at low-pressure (4 to 6 atmospheres), each separated by 1 min of reflow.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Fundación para la Investigación del Hospital Clínico de Valencia

    lead OTHER

Principal Investigators

  • Vicente Bodí · Cardiology Department. Hospital Clinico Universitario-INCLIVA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Spain

Study Locations

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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 NCT01898546 on ClinicalTrials.gov