NCT01898546

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
243

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

October 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
Last Updated

July 12, 2013

Status Verified

January 1, 2013

Enrollment Period

9 months

First QC Date

July 9, 2013

Last Update Submit

July 9, 2013

Conditions

Myocardial Infarction

Keywords

Ischemic postconditioningMyocardial InfarctionMicrovascular Obstruction

Outcome Measures

Primary Outcomes (1)

  • Microvascular obstruction

    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

    1 week

Secondary Outcomes (1)

  • Infarct size

    1 week

Study Arms (2)

Primary angioplasty and postconditioning

EXPERIMENTAL

Primary angioplasty followed by postconditioning

Procedure: Primary angioplastyProcedure: Postconditioning

Primary angioplasty

ACTIVE COMPARATOR

Primary angioplasty alone

Procedure: Primary angioplasty

Interventions

Primary angioplastyPROCEDURE

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.

Primary angioplastyPrimary angioplasty and postconditioning
PostconditioningPROCEDURE

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.

Primary angioplasty and postconditioning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Department. Hospital Clinico Universitario-INCLIVA. University of Valencia.

Valencia, Valencia, 46010, Spain

Location

Related Publications (1)

  • Bodi V, Ruiz-Nodar JM, Feliu E, Minana G, Nunez J, Husser O, Martinez-Elvira J, Ruiz A, Bonanad C, Monmeneu JV, Lopez-Lereu MP, Forteza MJ, de Dios E, Hervas A, Moratal D, Gomez C, Mainar L, Sanchis J, Mainar V, Valencia J, Diaz A, Noguera I, Chaustre F, Chorro FJ. Effect of ischemic postconditioning on microvascular obstruction in reperfused myocardial infarction. Results of a randomized study in patients and of an experimental model in swine. Int J Cardiol. 2014 Jul 15;175(1):138-46. doi: 10.1016/j.ijcard.2014.05.003. Epub 2014 May 10.

    PMID: 24856802DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Ischemic Postconditioning

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Vicente Bodí

    Cardiology Department. Hospital Clinico Universitario-INCLIVA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 12, 2013

Study Start

October 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 12, 2013

Record last verified: 2013-01

Locations

ES(1)