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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03725826
Other study ID # 13-01-023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2013
Est. completion date September 2016

Study information

Verified date October 2018
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Given the existing controversy regarding the appropriate determination time for placement of implantable cardioverter-defibrillator (ICD) in patients at risk for sudden cardiac death (SCD) following acute myocardial infarction (AMI), the modest ability of current criteria to determine which patients will experience SCD, and the high impact of SCD to society, we propose to conduct a prospective non-randomized observational study to determine:

- Whether quantification of left ventricular (LV) scar volume by cardiac magnetic resonance (CMRI) prior to hospital discharge helps to predict which patients will have a low ejection fraction (35%) at follow up and qualify for ICD implantation.

- Whether quantification of infarct scar volume by CMRI will help to identify which patients will experience malignant ventricular arrhythmias and/or SCD at follow-up, independent of the LV ejection fraction (LVEF).

Primary hypothesis:

Percentage of left ventricular scar volume as measured by CMRI post-MI strongly correlates with LVEF at 40 days and 3 months.

Secondary hypothesis:

1. A volume of >40% of left ventricular scar measured by CMRI post-MI is predictive of LVEF less than 35% at 40 days and at 3 months

2. Volume scar as measured by Cardiac magnetic resonance imaging after AMI (at day 5) is predictive of clinical outcomes: SCD, total mortality, heart failure admission and life-threatening malignant ventricular arrhythmias regardless of ejection fraction at 40 days and at 3 months.

Safety hypothesis:

ICDs will be implanted if patients meet criteria at 40 days post MI as per the current American College of Cardiology (ACC) /American Heart Association (AHA) /Heart Rhythm Society (HRS) 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Evidence of AMI either ST segment elevation or Non-ST segment elevation MI by biomarkers of cardiac injury and symptoms. Cut-off for creatine phosphokinase (CPK) >2 times and troponin >3 times the upper limit for the lab. Only Patients who undergo coronary revascularization (PCI, CABG) will be enrolled.

- LVEF < 45%. (Based on 10 points SD in echo measurements for LVEF)

- NYHA functional class I-III

- Patients aged 18 or above, both genders.

Exclusion Criteria:

- Patients with spontaneous or induced sustained ventricular tachycardia after 48-72 hours. (30 beats or more at 120 bpm or greater)

- Absolute contraindications to undergo CMRI (Renal failure with GFR<30% or ICD/PPM)

- Antiarrhythmic medications for ventricular arrhythmias (other than beta-blockers)

- Severe non-ischemic cardiac pathology. (e.g., ARVD, HCM, severe, restrictive cardiomyopathies (amiloydosis/sarcoidosis). We are aware that non-ischemic and ischemic cardiomyopathy may co-exist. However, these cardiomyopathies convey further arrhythmic risk and diffuse LV impairment.

- Unwilling or unable to provide informed consent

- Life expectancy less than 1 year.

- Current drug or alcohol abuse.

- Pregnancy

- Claustrophobia

- Patients who are enrolled in other trials with a treatment arm. (Patients enrolled in diagnostic trials can be included).

- Difficulty to attend the follow-up schedule due to a history of medical noncompliance, living a distance from the study center, or anticipated nonresidence in the area for the length of time required for follow-up.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Montefiore Medical Center, Albert Einstein College of Medicine Bronx New York

Sponsors (2)

Lead Sponsor Collaborator
Montefiore Medical Center Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (22)

Adabag AS, Therneau TM, Gersh BJ, Weston SA, Roger VL. Sudden death after myocardial infarction. JAMA. 2008 Nov 5;300(17):2022-9. doi: 10.1001/jama.2008.553. — View Citation

Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, Hochman JS, Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pearle DL, Sloan MA, Smith SC Jr; American College of Cardiology; American Heart Association; Canadian Cardiovascular Society. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction--executive summary. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1999 guidelines for the management of patients with acute myocardial infarction). J Am Coll Cardiol. 2004 Aug 4;44(3):671-719. Erratum in: J Am Coll Cardiol. 2005 Apr 19;45(8):1376. — View Citation

Bailey JJ, Berson AS, Handelsman H, Hodges M. Utility of current risk stratification tests for predicting major arrhythmic events after myocardial infarction. J Am Coll Cardiol. 2001 Dec;38(7):1902-11. — View Citation

Bigger JT Jr. Prophylactic use of implanted cardiac defibrillators in patients at high risk for ventricular arrhythmias after coronary-artery bypass graft surgery. Coronary Artery Bypass Graft (CABG) Patch Trial Investigators. N Engl J Med. 1997 Nov 27;337(22):1569-75. — View Citation

Burns RJ, Gibbons RJ, Yi Q, Roberts RS, Miller TD, Schaer GL, Anderson JL, Yusuf S; CORE Study Investigators. The relationships of left ventricular ejection fraction, end-systolic volume index and infarct size to six-month mortality after hospital discharge following myocardial infarction treated by thrombolysis. J Am Coll Cardiol. 2002 Jan 2;39(1):30-6. — View Citation

Buxton AE, Lee KL, DiCarlo L, Gold MR, Greer GS, Prystowsky EN, O'Toole MF, Tang A, Fisher JD, Coromilas J, Talajic M, Hafley G. Electrophysiologic testing to identify patients with coronary artery disease who are at risk for sudden death. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med. 2000 Jun 29;342(26):1937-45. — View Citation

Buxton AE, Lee KL, Fisher JD, Josephson ME, Prystowsky EN, Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med. 1999 Dec 16;341(25):1882-90. Erratum in: N Engl J Med 2000 Apr 27;342(17):1300. — View Citation

de Bakker JM, van Capelle FJ, Janse MJ, Tasseron S, Vermeulen JT, de Jonge N, Lahpor JR. Slow conduction in the infarcted human heart. 'Zigzag' course of activation. Circulation. 1993 Sep;88(3):915-26. — View Citation

Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Faxon DP, Halperin JL, Hiratzka LF, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura RA, Ornato JP, Page RL, Riegel B, Tarkington LG, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices); American Association for Thoracic Surgery; Society of Thoracic Surgeons. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008 May 27;51(21):e1-62. doi: 10.1016/j.jacc.2008.02.032. Erratum in: J Am Coll Cardiol. 2009 Apr 21;53(16):1473. J Am Coll Cardiol. 2009 Jan 6;53(1):147. — View Citation

Hohnloser SH, Kuck KH, Dorian P, Roberts RS, Hampton JR, Hatala R, Fain E, Gent M, Connolly SJ; DINAMIT Investigators. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction. N Engl J Med. 2004 Dec 9;351(24):2481-8. — View Citation

Hundley WG, Meshack BM, Willett DL, Sayad DE, Lange RA, Willard JE, Landau C, Hillis LD, Peshock RM. Comparison of quantitation of left ventricular volume, ejection fraction, and cardiac output in patients with atrial fibrillation by cine magnetic resonance imaging versus invasive measurements. Am J Cardiol. 1996 Nov 15;78(10):1119-23. — View Citation

Kumar S, Sivagangabalan G, Zaman S, West EB, Narayan A, Thiagalingam A, Kovoor P. Electrophysiology-guided defibrillator implantation early after ST-elevation myocardial infarction. Heart Rhythm. 2010 Nov;7(11):1589-97. doi: 10.1016/j.hrthm.2010.07.019. Epub 2010 Jul 19. — View Citation

Marrouche NF, Verma A, Wazni O, Schweikert R, Martin DO, Saliba W, Kilicaslan F, Cummings J, Burkhardt JD, Bhargava M, Bash D, Brachmann J, Guenther J, Hao S, Beheiry S, Rossillo A, Raviele A, Themistoclakis S, Natale A. Mode of initiation and ablation of ventricular fibrillation storms in patients with ischemic cardiomyopathy. J Am Coll Cardiol. 2004 May 5;43(9):1715-20. — View Citation

Moss AJ, Hall WJ, Cannom DS, Daubert JP, Higgins SL, Klein H, Levine JH, Saksena S, Waldo AL, Wilber D, Brown MW, Heo M. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med. 1996 Dec 26;335(26):1933-40. — View Citation

Multicenter Postinfarction Research Group. Risk stratification and survival after myocardial infarction. N Engl J Med. 1983 Aug 11;309(6):331-6. — View Citation

Ndrepepa G, Mehilli J, Martinoff S, Schwaiger M, Schömig A, Kastrati A. Evolution of left ventricular ejection fraction and its relationship to infarct size after acute myocardial infarction. J Am Coll Cardiol. 2007 Jul 10;50(2):149-56. Epub 2007 Jun 21. Erratum in: J Am Coll Cardiol. 2007 Oct 23;50(17):1733. — View Citation

Newby KH, Thompson T, Stebbins A, Topol EJ, Califf RM, Natale A. Sustained ventricular arrhythmias in patients receiving thrombolytic therapy: incidence and outcomes. The GUSTO Investigators. Circulation. 1998 Dec 8;98(23):2567-73. — View Citation

Sheehan FH, Doerr R, Schmidt WG, Bolson EL, Uebis R, von Essen R, Effert S, Dodge HT. Early recovery of left ventricular function after thrombolytic therapy for acute myocardial infarction: an important determinant of survival. J Am Coll Cardiol. 1988 Aug;12(2):289-300. — View Citation

Solomon SD, Glynn RJ, Greaves S, Ajani U, Rouleau JL, Menapace F, Arnold JM, Hennekens C, Pfeffer MA. Recovery of ventricular function after myocardial infarction in the reperfusion era: the healing and early afterload reducing therapy study. Ann Intern Med. 2001 Mar 20;134(6):451-8. — View Citation

Ureña PE, Lamas GA, Mitchell G, Flaker GC, Smith SC Jr, Wackers FJ, McEwan P, Pfeffer MA. Ejection fraction by radionuclide ventriculography and contrast left ventriculogram. A tale of two techniques. SAVE Investigators. Survival and Ventricular Enlargement. J Am Coll Cardiol. 1999 Jan;33(1):180-5. — View Citation

Zaret BL, Wackers FJ, Terrin ML, Forman SA, Williams DO, Knatterud GL, Braunwald E. Value of radionuclide rest and exercise left ventricular ejection fraction in assessing survival of patients after thrombolytic therapy for acute myocardial infarction: results of Thrombolysis in Myocardial Infarction (TIMI) phase II study. The TIMI Study Group. J Am Coll Cardiol. 1995 Jul;26(1):73-9. — View Citation

Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C, Smith SC Jr, Jacobs AK, Adams CD, Antman EM, Anderson JL, Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B, Blanc JJ, Budaj A, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology/American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (writing committee to develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006 Sep 5;114(10):e385-484. Epub 2006 Aug 25. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Repeated Emergency Department visits Safety outcomes include repeat Emergency Department (ED) visits, hospital admissions and major adverse cardiovascular events (all-cause mortality, cardiac death, non-fatal myocardial infarction and stroke). Performance of subsequent cardiac imaging studies, cardiac catheterization and coronary interventions will also be monitored as a reflection of test efficiency. At 40 days post-MI
Other Hospital admissions Safety outcomes include include repeat ED visits, hospital admissions and major adverse cardiovascular events (all-cause mortality, cardiac death, non-fatal myocardial infarction and stroke). Performance of subsequent cardiac imaging studies, cardiac catheterization and coronary interventions will also be monitored as a reflection of test efficiency. At 40 days post-MI
Other All-cause mortality Safety outcomes include include repeat ED visits, hospital admissions and major adverse cardiovascular events (all-cause mortality, cardiac death, non-fatal myocardial infarction and stroke). Performance of subsequent cardiac imaging studies, cardiac catheterization and coronary interventions will also be monitored as a reflection of test efficiency. At 40 days post-MI
Other Cardiac death Safety outcomes include include repeat ED visits, hospital admissions and major adverse cardiovascular events (all-cause mortality, cardiac death, non-fatal myocardial infarction and stroke). Performance of subsequent cardiac imaging studies, cardiac catheterization and coronary interventions will also be monitored as a reflection of test efficiency. At 40 days post-MI
Other non-fatal myocardial infarction Safety outcomes include include repeat ED visits, hospital admissions and major adverse cardiovascular events (all-cause mortality, cardiac death, non-fatal myocardial infarction and stroke). Performance of subsequent cardiac imaging studies, cardiac catheterization and coronary interventions will also be monitored as a reflection of test efficiency. At 40 days post-MI
Other Incidents of Stroke Safety outcomes include include repeat ED visits, hospital admissions and major adverse cardiovascular events (all-cause mortality, cardiac death, non-fatal myocardial infarction and stroke). Performance of subsequent cardiac imaging studies, cardiac catheterization and coronary interventions will also be monitored as a reflection of test efficiency. At 40 days post-MI
Primary Change in LVEF in post MI patients The degree of LVEF recovery after a first MI provides important prognostic information. Patients with no recovery in LVEF after MI are at high risk of sudden cardiac arrest events and death. 40 days post-MI and 3 months post-MI
Secondary LVEF less than 35% The degree of LVEF recovery after a first MI provides important prognostic information. Patients with no recovery in LVEF after MI are at high risk of sudden cardiac arrest events and death. At 40 days post-MI
Secondary Cardiovascular Mortality Cardiovascular mortality in patients was defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident. At 40 days post-MI
Secondary Cardiovascular Mortality Cardiovascular mortality in patients was defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident. at 3 months post-MI
Secondary Sustained ventricular tachycardia (VT) Sustained ventricular tachycardia (VT) is a ventricular rhythm faster than 100 bpm lasting at least 30 seconds or requiring termination earlier due to hemodynamic instability. VT is defined as a wide complex tachycardia (QRS 120 milliseconds or greater) that originates from one of the ventricles, and is not due to aberrant conduction (e.g., from bundle branch block), at a rate of 100 bpm or greater. At 40 days post-MI
Secondary Sustained ventricular fibrillation (VF) Sustained ventricular fibrillation is malignant arrhythmia At 40 days post-MI
Secondary Sustained ventricular tachycardia (VT) Sustained ventricular tachycardia (VT) is a ventricular rhythm faster than 100 bpm lasting at least 30 seconds or requiring termination earlier due to hemodynamic instability. VT is defined as a wide complex tachycardia (QRS 120 milliseconds or greater) that originates from one of the ventricles, and is not due to aberrant conduction (e.g., from bundle branch block), at a rate of 100 bpm or greater. At 3 months post-MI
Secondary Sustained ventricular fibrillation (VF) Sustained ventricular fibrillation is malignant arrhythmia At 3 months post-MI
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