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Myocardial Reperfusion InjuryPhase 2POST-AMINCT01004289

POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study

A Phase 2 study testing Postconditioning and Primary angioplasty and stenting without additional intervention in people with Myocardial Reperfusion Injury, run by University of Padova at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Reperfusion Injury
What is being tested?
Postconditioning and Primary angioplasty and stenting without additional intervention
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteItaly
Study dates
Apr 2007to Apr 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 17Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy

    Padua, 35128

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
Postconditioning, Primary angioplasty and stenting without additional intervention
Keywords
Acute myocardial infarction, Primary percutaneous coronary intervention, Postconditioning
Medical subject headings
Myocardial Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PostconditioningProcedure or surgery

    Also called Staccato Reperfusion

    Primary angioplasty and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion

  • Primary angioplasty and stenting without additional interventionProcedure or surgery

    Primary angioplasty and stenting without additional intervention.

Study groups in NCT01004289
Study groupRoleWhat they receive
ControlActive comparatorPrimary angioplasty and stenting without additional intervention.
Receives: Procedure: Primary angioplasty and stenting without additional intervention
PostconditioningExperimentalPrimary angioplasty and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion.
Receives: Procedure: Postconditioning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infarct size estimated by magnetic resonance

    Measured: 30±10 days after myocardial infartion

Secondary outcomes (8)

  1. Microvascular obstruction observed at magnetic resonance

    Measured: 30±10 days after myocardial infarction

  2. ST-segment elevation resolution

    Measured: First post-intervention ECG

  3. Persistent ST-segment elevation

    Measured: At 24 and 48 hours post-intervention ECG

  4. Angiographic myocardial blush grade <2

    Measured: After primary angioplasty

  5. Non sustained/sustained ventricular tachycardia

    Measured: Within 48 hours after miocardial infarction

  6. Enzymatic infarct size

    Measured: Within 7 days after myocardial infarction

  7. Left ventricular remodeling and left ventricular function at MRI

    Measured: At 6±1 months

  8. Incidence of Major Adverse Cardiac Events (MACE), defined as the combination of death, re-infarction, re-hospitalization for heart failure or repeat revascularization

    Measured: At 30 days and at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2009 (estimated)
  2. Study startApr 2007
  3. Primary completionJan 2010
  4. Study completionApr 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01004289
Sponsor's protocol ID
1328P
Acronym
POST-AMI
Status last verified
Oct 2010
First submitted
28 Oct 2009
Last updated
15 Oct 2010
Results posted
No
Data monitoring committee
No

Publications

  • Thom T, Haase N, Rosamond W, Howard VJ, Rumsfeld J, Manolio T, Zheng ZJ, Flegal K, O'Donnell C, Kittner S, Lloyd-Jones D, Goff DC Jr, Hong Y, Adams R, Friday G, Furie K, Gorelick P, Kissela B, Marler J, Meigs J, Roger V, Sidney S, Sorlie P, Steinberger J, Wasserthiel-Smoller S, Wilson M, Wolf P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2006 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2006 Feb 14;113(6):e85-151. doi: 10.1161/CIRCULATIONAHA.105.171600. Epub 2006 Jan 11. No abstract available.

    PubMed 16407573

  • Reffelmann T, Hale SL, Li G, Kloner RA. Relationship between no reflow and infarct size as influenced by the duration of ischemia and reperfusion. Am J Physiol Heart Circ Physiol. 2002 Feb;282(2):H766-72. doi: 10.1152/ajpheart.00767.2001.

    PubMed 11788428

  • Vinten-Johansen J, Yellon DM, Opie LH. Postconditioning: a simple, clinically applicable procedure to improve revascularization in acute myocardial infarction. Circulation. 2005 Oct 4;112(14):2085-8. doi: 10.1161/CIRCULATIONAHA.105.569798. No abstract available.

    PubMed 16203924

  • Staat P, Rioufol G, Piot C, Cottin Y, Cung TT, L'Huillier I, Aupetit JF, Bonnefoy E, Finet G, Andre-Fouet X, Ovize M. Postconditioning the human heart. Circulation. 2005 Oct 4;112(14):2143-8. doi: 10.1161/CIRCULATIONAHA.105.558122. Epub 2005 Sep 26.

    PubMed 16186417

  • Ottani F, Galvani M, Ferrini D, Sorbello F, Limonetti P, Pantoli D, Rusticali F. Prodromal angina limits infarct size. A role for ischemic preconditioning. Circulation. 1995 Jan 15;91(2):291-7. doi: 10.1161/01.cir.91.2.291.

    PubMed 7805230

  • Kloner RA, Shook T, Antman EM, Cannon CP, Przyklenk K, Yoo K, McCabe CH, Braunwald E. Prospective temporal analysis of the onset of preinfarction angina versus outcome: an ancillary study in TIMI-9B. Circulation. 1998 Mar 24;97(11):1042-5. doi: 10.1161/01.cir.97.11.1042.

    PubMed 9531250

  • 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. doi: 10.1161/CIRCULATIONAHA.105.170815. No abstract available.

    PubMed 16391169

  • van 't Hof AW, Liem A, Suryapranata H, Hoorntje JC, de Boer MJ, Zijlstra F. Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade. Zwolle Myocardial Infarction Study Group. Circulation. 1998 Jun 16;97(23):2302-6. doi: 10.1161/01.cir.97.23.2302.

    PubMed 9639373

  • Svilaas T, van der Horst IC, Zijlstra F. Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS)--study design. Am Heart J. 2006 Mar;151(3):597.e1-597.e7. doi: 10.1016/j.ahj.2005.11.010.

    PubMed 16504620

  • Kim RJ, Shah DJ, Judd RM. How we perform delayed enhancement imaging. J Cardiovasc Magn Reson. 2003 Jul;5(3):505-14. doi: 10.1081/jcmr-120022267.

    PubMed 12882082

  • Cerqueira MD, Weissman NJ, Dilsizian V, Jacobs AK, Kaul S, Laskey WK, Pennell DJ, Rumberger JA, Ryan T, Verani MS; American Heart Association Writing Group on Myocardial Segmentation and Registration for Cardiac Imaging. Standardized myocardial segmentation and nomenclature for tomographic imaging of the heart. A statement for healthcare professionals from the Cardiac Imaging Committee of the Council on Clinical Cardiology of the American Heart Association. Circulation. 2002 Jan 29;105(4):539-42. doi: 10.1161/hc0402.102975. No abstract available.

    PubMed 11815441

  • Judd RM, Lugo-Olivieri CH, Arai M, Kondo T, Croisille P, Lima JA, Mohan V, Becker LC, Zerhouni EA. Physiological basis of myocardial contrast enhancement in fast magnetic resonance images of 2-day-old reperfused canine infarcts. Circulation. 1995 Oct 1;92(7):1902-10. doi: 10.1161/01.cir.92.7.1902.

    PubMed 7671375

  • Lima JA, Judd RM, Bazille A, Schulman SP, Atalar E, Zerhouni EA. Regional heterogeneity of human myocardial infarcts demonstrated by contrast-enhanced MRI. Potential mechanisms. Circulation. 1995 Sep 1;92(5):1117-25. doi: 10.1161/01.cir.92.5.1117.

    PubMed 7648655

  • Braunwald E, Domanski MJ, Fowler SE, Geller NL, Gersh BJ, Hsia J, Pfeffer MA, Rice MM, Rosenberg YD, Rouleau JL; PEACE Trial Investigators. Angiotensin-converting-enzyme inhibition in stable coronary artery disease. N Engl J Med. 2004 Nov 11;351(20):2058-68. doi: 10.1056/NEJMoa042739. Epub 2004 Nov 7.

    PubMed 15531767

  • Tarantini G, Favaretto E, Marra MP, Frigo AC, Napodano M, Cacciavillani L, Giovagnoni A, Renda P, De Biasio V, Plebani M, Mion M, Zaninotto M, Isabella G, Bilato C, Iliceto S. Postconditioning during coronary angioplasty in acute myocardial infarction: the POST-AMI trial. Int J Cardiol. 2012 Dec 15;162(1):33-8. doi: 10.1016/j.ijcard.2012.03.136. Epub 2012 Apr 9.

    PubMed 22494866

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Postconditioning and Primary angioplasty and stenting without additional intervention in people with Myocardial Reperfusion Injury, run by University of Padova at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infarct size estimated by magnetic resonance (time frame: 30±10 days after myocardial infartion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01004289, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2010.

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