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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01004289
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : October 15, 2010
Sponsor:
Information provided by:
University of Padova

Tracking Information
First Submitted Date  ICMJE October 28, 2009
First Posted Date  ICMJE October 29, 2009
Last Update Posted Date October 15, 2010
Study Start Date  ICMJE April 2007
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
Infarct size estimated by magnetic resonance [ Time Frame: 30±10 days after myocardial infartion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
  • Microvascular obstruction observed at magnetic resonance [ Time Frame: 30±10 days after myocardial infarction ]
  • ST-segment elevation resolution [ Time Frame: First post-intervention ECG ]
  • Persistent ST-segment elevation [ Time Frame: At 24 and 48 hours post-intervention ECG ]
  • Angiographic myocardial blush grade <2 [ Time Frame: After primary angioplasty ]
  • Non sustained/sustained ventricular tachycardia [ Time Frame: Within 48 hours after miocardial infarction ]
  • Enzymatic infarct size [ Time Frame: Within 7 days after myocardial infarction ]
  • Left ventricular remodeling and left ventricular function at MRI [ Time Frame: At 6±1 months ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study
Official Title  ICMJE POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study (POST-AMI)
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Reperfusion Injury
Intervention  ICMJE
  • Procedure: Postconditioning
    Primary angioplasty and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion
    Other Name: Staccato Reperfusion
  • Procedure: Primary angioplasty and stenting without additional intervention
    Primary angioplasty and stenting without additional intervention.
Study Arms  ICMJE
  • Active Comparator: Control
    Primary angioplasty and stenting without additional intervention.
    Intervention: Procedure: 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.
    Intervention: Procedure: Postconditioning
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2009)
78
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01004289
Other Study ID Numbers  ICMJE 1328P
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Giuseppe Tarantini, Department of Cardiac, Thoracic and Vascular Sciences. University of Padua
Study Sponsor  ICMJE University of Padova
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Giuseppe Tarantini, MD, Ph.D. Department of Cardiac, Thoracic and Vascular Sciences, University of Padua
PRS Account University of Padova
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP