POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study

NCT01004289 | Completed Phase 2

• 1 other identifier: 1328P
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Reperfusion Injury

Keywords

Acute myocardial infarction; Primary percutaneous coronary intervention; Postconditioning

Outcome Measures

Primary Outcomes (1)

• Infarct size estimated by magnetic resonance

  30±10 days after myocardial infartion

Secondary Outcomes (8)

• Microvascular obstruction observed at magnetic resonance

  30±10 days after myocardial infarction

• ST-segment elevation resolution

  First post-intervention ECG

• Persistent ST-segment elevation

  At 24 and 48 hours post-intervention ECG

• Angiographic myocardial blush grade <2

  After primary angioplasty

• Non sustained/sustained ventricular tachycardia

  Within 48 hours after miocardial infarction

Study Arms (2)

Control

ACTIVE COMPARATOR

Primary angioplasty and stenting without additional intervention.

Procedure: Primary angioplasty and stenting without additional intervention

Postconditioning

EXPERIMENTAL

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

Procedure: Postconditioning

Interventions

Postconditioning PROCEDURE

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

Also known as: Staccato Reperfusion

Postconditioning

Primary angioplasty and stenting without additional intervention PROCEDURE

Primary angioplasty and stenting without additional intervention.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

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

Padua, 35128, Italy

Location

Related Publications (16)

• 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.

  PMID: 16407573 BACKGROUND

• 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.

  PMID: 11788428 BACKGROUND

• 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.

  PMID: 16203924 BACKGROUND

• 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.

  PMID: 16186417 BACKGROUND

• 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.

  PMID: 7805230 BACKGROUND

• 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.

  PMID: 9531250 BACKGROUND

• 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.

  PMID: 16391169 BACKGROUND

• 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.

  PMID: 9639373 BACKGROUND

• 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.

  PMID: 16504620 BACKGROUND

• 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.

  PMID: 12882082 BACKGROUND

• 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.

  PMID: 11815441 BACKGROUND

• 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.

  PMID: 7671375 BACKGROUND

• 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.

  PMID: 7648655 BACKGROUND

• 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.

  PMID: 15531767 BACKGROUND

• 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.

  PMID: 22494866 DERIVED

• Tarantini G, Favaretto E, Napodano M, Perazzolo Marra M, Cacciavillani L, Babuin L, Giovagnoni A, Renda P, De Biasio V, Plebani M, Mion M, Zaninotto M, Mistrorigo F, Panfili M, Isabella G, Bilato C, Iliceto S. Design and methodologies of the POSTconditioning during coronary angioplasty in acute myocardial infarction (POST-AMI) trial. Cardiology. 2010;116(2):110-6. doi: 10.1159/000316967. Epub 2010 Jun 29.

  PMID: 20588019 DERIVED

MeSH Terms

Conditions

Myocardial Reperfusion Injury

Interventions

Ischemic Postconditioning; Stents

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Reperfusion Injury; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Prostheses and Implants; Equipment and Supplies

Study Officials

• Giuseppe Tarantini, MD, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 29, 2009
• Study Start: April 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: April 1, 2010
• Last Updated: October 15, 2010

Record last verified: 2010-10

Locations

IT (1)