POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study

Myocardial Reperfusion Injury Clinical Trial

— POST-AMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004289
• Other study ID #: 1328P
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2009
• Last updated: October 14, 2010
• Start date: April 2007
• Est. completion date: April 2010

Study information

• Verified date: October 2010
• Source: University of Padua
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Reperfusion Injury
• Reperfusion Injury

Intervention

Procedure:
• Postconditioning
Primary angioplasty and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion
• Primary angioplasty and stenting without additional intervention
Primary angioplasty and stenting without additional intervention.

Locations

Country	Name	City	State
Italy	Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy	Padua

Sponsors (1)

Lead Sponsor	Collaborator
University of Padua

Country where clinical trial is conducted

Italy, 

References & Publications (14)

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. Epub 2004 Nov 7. — View Citation

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. Review. — View Citation

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. — View Citation

Kim RJ, Shah DJ, Judd RM. How we perform delayed enhancement imaging. J Cardiovasc Magn Reson. 2003 Jul;5(3):505-14. Erratum in: J Cardiovasc Magn Reson. 2003;5(4):613-5. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Staat P, Rioufol G, Piot C, Cottin Y, Cung TT, L'Huillier I, Aupetit JF, Bonnefoy E, Finet G, André-Fouët X, Ovize M. Postconditioning the human heart. Circulation. 2005 Oct 4;112(14):2143-8. Epub 2005 Sep 26. — View Citation

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. — View Citation

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. Epub 2006 Jan 11. Erratum in: Circulation. 2006 Apr 11;113(14):e696. Circulation. 2006 Dec 5;114(23):e630. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

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