Ischemic Postconditioning on Microvascular Obstruction in Reperfused Myocardial Infarction (POSTRE)

This study has been completed.
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier:
NCT01898546
First received: July 9, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Myocardial Infarction
Procedure: Primary angioplasty
Procedure: Postconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Ischemic Postconditioning on Microvascular Obstruction in Reperfused Myocardial Infarction. Results of a Randomized Study in Patients

Resource links provided by NLM:


Further study details as provided by Fundación para la Investigación del Hospital Clínico de Valencia:

Primary Outcome Measures:
  • Microvascular obstruction [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Microvascular obstruction will be visually defined as a lack of contrast uptake in the core of tissue showing late gadolinium enhancement; the extent of microvascular obstruction will be manually defined and expressed as percentage of LV mass


Secondary Outcome Measures:
  • Infarct size [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Infarct size will be derived from late gadolinium enhancement and will be considered to be present if signal intensity is >2 standard deviations with respect to a sample of remote non-infarcted myocardium in late gadolinium enhancement imaging


Enrollment: 243
Study Start Date: October 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Primary angioplasty and postconditioning
Primary angioplasty followed by postconditioning
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.
Active Comparator: Primary angioplasty
Primary angioplasty alone
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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of age ≥ 18 years admitted to two university hospitals for a first STEMI within the first 12 h of chest pain onset, with ST-segment elevation of >0.1 mV in at least 2 contiguous leads and for whom the clinical decision to treat with percutaneous coronary intervention is made.

Exclusion Criteria:

  • Documented history of previous infarction
  • Primary percutaneous revascularization not attempted
  • Severe clinical or hemodynamic deterioration
  • Left main stem disease
  • Thrombolysis In Myocardial Infarction (TIMI) 2-3
  • Rentrop collateral flow grade ≥1 upon patient arrival
  • Death, re-infarction, cardiac surgery or severe clinical deterioration before CMR study
  • Patients who denied participation in the registry
  • Any contraindications to CMR
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01898546

Locations
Spain
Cardiology Department. Hospital Clinico Universitario-INCLIVA. University of Valencia.
Valencia, Spain, 46010
Sponsors and Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia
Instituto de Salud Carlos III
Investigators
Principal Investigator: Vicente Bodí Cardiology Department. Hospital Clinico Universitario-INCLIVA
  More Information

No publications provided by Fundación para la Investigación del Hospital Clínico de Valencia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier: NCT01898546     History of Changes
Other Study ID Numbers: 2011/012
Study First Received: July 9, 2013
Last Updated: July 9, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Fundación para la Investigación del Hospital Clínico de Valencia:
Ischemic postconditioning
Myocardial Infarction
Microvascular Obstruction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014