POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study (POST-AMI)

This study has been completed.
Sponsor:
Information provided by:
University of Padua
ClinicalTrials.gov Identifier:
NCT01004289
First received: October 28, 2009
Last updated: October 14, 2010
Last verified: October 2010
  Purpose

The POST-conditioning during coronary angioplasty in Acute Myocardial Infarction (POST-AMI) trial will evaluate the usefulness of postconditioning in limiting infarct size and microvascular damage during the early and late phases after AMI.


Condition Intervention Phase
Myocardial Reperfusion Injury
Procedure: Postconditioning
Procedure: Primary angioplasty and stenting without additional intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study (POST-AMI)

Resource links provided by NLM:


Further study details as provided by University of Padua:

Primary Outcome Measures:
  • Infarct size estimated by magnetic resonance [ Time Frame: 30±10 days after myocardial infartion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Microvascular obstruction observed at magnetic resonance [ Time Frame: 30±10 days after myocardial infarction ] [ Designated as safety issue: No ]
  • ST-segment elevation resolution [ Time Frame: First post-intervention ECG ] [ Designated as safety issue: No ]
  • Persistent ST-segment elevation [ Time Frame: At 24 and 48 hours post-intervention ECG ] [ Designated as safety issue: No ]
  • Angiographic myocardial blush grade <2 [ Time Frame: After primary angioplasty ] [ Designated as safety issue: No ]
  • Non sustained/sustained ventricular tachycardia [ Time Frame: Within 48 hours after miocardial infarction ] [ Designated as safety issue: No ]
  • Enzymatic infarct size [ Time Frame: Within 7 days after myocardial infarction ] [ Designated as safety issue: No ]
  • Left ventricular remodeling and left ventricular function at MRI [ Time Frame: At 6±1 months ] [ Designated as safety issue: No ]
  • Incidence of Major Adverse Cardiac Events (MACE), defined as the combination of death, re-infarction, re-hospitalization for heart failure or repeat revascularization [ Time Frame: At 30 days and at 6 months ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: April 2007
Study Completion Date: April 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Primary angioplasty and stenting without additional intervention.
Procedure: Primary angioplasty and stenting without additional intervention
Primary angioplasty and stenting without additional intervention.
Experimental: Postconditioning
Primary angioplasty and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion.
Procedure: Postconditioning
Primary angioplasty and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion
Other Name: Staccato Reperfusion

Detailed Description:

POST-AMI is a single-center, prospective, randomized trial, with a planned inclusion of 78 patients with ST-elevation Acute Myocardial Infarction (AMI). Patients will be randomly assigned to postconditioning arm (primary angioplasty (PA) and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion) or non-postconditioning arm (PA and stenting without additional intervention). All patients will be treated medically according to current international guidelines, including glycoprotein IIb/IIIa inhibitors before PCI. The primary end point is to evaluate whether postconditioning, compared to PA without additional intervention, reduces infarct size estimated by magnetic resonance at 30±10 days after the AMI. Secondary end points are microvascular obstruction observed at magnetic resonance, ST-segment elevation resolution, persistent ST-segment elevation, angiographic myocardial blush grade <2 and non sustained/sustained ventricular tachycardia in the 48 hours following PA. Further secondary end points are enzymatic infarct size, left ventricular remodeling and left ventricular function at magnetic resonance performed at 6±1 months, and the reduction of major adverse cardiac events at 30 days and 6 months.

  Eligibility

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

Inclusion Criteria:

  • clinical evidence of myocardial infarction defined by the presence of ischemic chest pain lasting more than 30 minutes, with a time interval from the onset of symptoms less than 6 hours before hospital admission, associated with typical ST-segment elevation on the 12-lead ECG
  • angiographic-detected culprit lesion with stenosis diameter >70% and TIMI flow grade <=1

Exclusion Criteria:

  • previous acute myocardial infarction
  • previous myocardial revascularization (angioplasty or coronary bypass)
  • previous heart valve replacement
  • previous heart transplant
  • clinical instability precluding the suitability of the study
  • cardiogenic shock or persistent hypotension (systolic blood pressure <100 mmHg)
  • rescue angioplasty after thrombolytic therapy
  • evidence of coronary collaterals (Rentrop grade>0) in the risk area
  • advanced atrioventricular block
  • significant bradycardia
  • absence of sinus rhythm
  • inability to lay flat (due to severe cardiac heart failure/respiratory insufficiency)
  • history or clinical evidence of bronchospastic lung disease
  • pregnancy
  • known existence of a life-threatening disease with a life expectancy <6 months
  • inability to give informed consent
  • any contraindication to undergo cardiac-MRI, such as implanted metallic objects (cardiac pacemakers and/or implantable cardioverter defibrillator, implanted insulin pumps or any other type of electronic devices, cerebral clips, aneurysm clips) or any other contraindication to cardiac-MRI (such as claustrophobia)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004289

Locations
Italy
Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy
Padua, Italy, 35128
Sponsors and Collaborators
University of Padua
Investigators
Principal Investigator: Giuseppe Tarantini, MD, Ph.D. Department of Cardiac, Thoracic and Vascular Sciences, University of Padua
  More Information

Publications:
Smith SC Jr, Feldman TE, Hirshfeld JW Jr, Jacobs AK, Kern MJ, King SB 3rd, Morrison DA, O'Neill WW, Schaff HV, Whitlow PL, Williams DO, Antman EM, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions Writting Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention. ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention--summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). Circulation. 2006 Jan 3;113(1):156-75. No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Giuseppe Tarantini, Department of Cardiac, Thoracic and Vascular Sciences. University of Padua
ClinicalTrials.gov Identifier: NCT01004289     History of Changes
Other Study ID Numbers: 1328P
Study First Received: October 28, 2009
Last Updated: October 14, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by University of Padua:
Acute myocardial infarction
Primary percutaneous coronary intervention
Postconditioning

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Reperfusion Injury
Myocardial Reperfusion Injury
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
Cardiomyopathies

ClinicalTrials.gov processed this record on September 16, 2014