- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05160311
Percutaneous Revascularization in Infarction With Late Presentation and Absence of Viability: Effects on Left Ventricular Remodeling and Contractility
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Barbara Valente, MD
- Phone Number: 5585988083444
- Email: barbaravalente@hotmail.com
Study Contact Backup
- Name: Pedro Farsky, MD, PhD
- Phone Number: 5511991662309
- Email: pedro.farsky@gmail.com
Study Locations
-
-
-
Sao Paulo, Brazil, 04012909
- Recruiting
- Instituto Dante Pazzanese de Cardiologia
-
Contact:
- BARBARA VALENTE, MD
- Phone Number: 551150856204
- Email: BARBARAVALENTE@HOTMAIL.COM
-
Contact:
- RENATA VIANA, MD
- Phone Number: 551150856204
- Email: RVIANA@DANTEPAZZANESE.ORG.BR
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- STEMI not reperfused between 24 hours and 28 days
- MI-related artery with > or = 50%
- Segmental dysfunction in the artery related to infarction.
- Technical feasibility for PCI recanalization
- Absence of Myocardial Viability
3.3 Exclusion criteria
- Age > 80 years
- < 1 year life expectancy
- Post MI Angina
- Clinical Instability
- Electrical Instability
- Previous Infarction with segment disfunction
- New York Heart Association (NYHA) class III or IV of heart failure.
- Previous diagnosis of congestive heart failure or cardiomyopathy
- Severe heart valve disease
- Absence of segmental dysfunction in the artery related to infarction
- Coronary angiography without obstructive lesions
- Indication of myocardial revascularization surgery
- Opted for clinical treatment for technical reasons
- Serum creatinine concentration greater than 2.5 mg/dl
- Pacemaker or Implantable Cardiodefibrillator (ICD)
- Brain Clip Carriers
- Patients with Cochlear Implants
- Refusal to sign the Informed Consent Form (ICF).
- Inability to maintain outpatient follow-up for 6 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Optimized Medical Treatment (OMT)
The patient considered non-viable by MRI and randomized to Optimized Medical Treatment (OMT) will be treated according to Optimized Medical Treatment guidelines for Coronary Artery Disease (CAD)
|
Optimized Medical Drug Treatment
|
Experimental: Angioplasty (PCI) and Optimized Medical Treatment (OMT)
The patient considered non-viable and randomized to Coronary Angioplasty will be treated with drug-eluting stent (PCI) and Optimized Medical Treatment (OMT)
|
Optimized Medical Drug Treatment
Percutaneous Angioplasty with DES
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reverse myocardial remodeling after late recanalization in patients without viability
Time Frame: 6 months
|
Evaluate reverse remodeling after late recanalization in patients without viability measuring End Systolic Volume (ESV) by MRI
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessement of Left Ventricle Ejection Fraction (LVEF)
Time Frame: 6 months
|
Change in LVEF measured by MRI The degree of LVEF recovery after a MI provides important prognostic information.
Patients with no recovery in LVEF after MI are at high risk of sudden cardiac arrest events and death.
|
6 months
|
Assessement of Myocardial contractility
Time Frame: 6 months
|
Evaluate the change of reverse LV remodeling after late recanalization assessed by MRI.
|
6 months
|
Evaluate Quality of Life
Time Frame: 6 months
|
Evaluate change from baseline in patients Quality of life using Abbreviated World Health Organization Quality of Life (WHOQOL-BREF) questionnaire. The WHOQOL-Bref (Field Trial Version) produces a profile with four domain scores and two individually scored items about an individual's overall perception of quality of life and health. The four domain scores are scaled in a positive direction with higher scores indicating a higher quality of life. The possible raw score ranges for each domain are as follows: Physical Health=28, Psychological=24, Social Relationships=12, and Environment=32. |
6 months
|
Acute MI Event
Time Frame: 6 months
|
Incidence of Acute Myocardial Infarct.
|
6 months
|
Unplanned revascularization (Ischemia Driven and Not Ischemia Driven)
Time Frame: 6 months
|
Incidence of Unplanned Myocardial revascularization (Ischemia Driven and Not Ischemia Driven) after hospital discharge
|
6 months
|
Cardiovascular Death
Time Frame: 6 months
|
Incidence of Cardiovascular Death.
Cardiac death is defined as any death in which a cardiac cause cannot be excluded.
(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).
|
6 months
|
Cardiovascular-Related Hospitalization
Time Frame: 6 months
|
Incidence of New Cardiovascular related Hospitalization after discharge
|
6 months
|
Stroke Event
Time Frame: 6 months
|
Incidence of Stroke Event Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Barbara Valente, MD, Instituto Dante Pazzanese de Cardiologia
Publications and helpful links
General Publications
- Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
- Kim RJ, Wu E, Rafael A, Chen EL, Parker MA, Simonetti O, Klocke FJ, Bonow RO, Judd RM. The use of contrast-enhanced magnetic resonance imaging to identify reversible myocardial dysfunction. N Engl J Med. 2000 Nov 16;343(20):1445-53. doi: 10.1056/NEJM200011163432003.
- Dzavik V, Beanlands DS, Davies RF, Leddy D, Marquis JF, Teo KK, Ruddy TD, Burton JR, Humen DP. Effects of late percutaneous transluminal coronary angioplasty of an occluded infarct-related coronary artery on left ventricular function in patients with a recent (< 6 weeks) Q-wave acute myocardial infarction (Total Occlusion Post-Myocardial Infarction Intervention Study [TOMIIS]--a pilot study). Am J Cardiol. 1994 May 1;73(12):856-61. doi: 10.1016/0002-9149(94)90809-5.
- Horie H, Takahashi M, Minai K, Izumi M, Takaoka A, Nozawa M, Yokohama H, Fujita T, Sakamoto T, Kito O, Okamura H, Kinoshita M. Long-term beneficial effect of late reperfusion for acute anterior myocardial infarction with percutaneous transluminal coronary angioplasty. Circulation. 1998 Dec 1;98(22):2377-82. doi: 10.1161/01.cir.98.22.2377.
- Hochman JS, Lamas GA, Buller CE, Dzavik V, Reynolds HR, Abramsky SJ, Forman S, Ruzyllo W, Maggioni AP, White H, Sadowski Z, Carvalho AC, Rankin JM, Renkin JP, Steg PG, Mascette AM, Sopko G, Pfisterer ME, Leor J, Fridrich V, Mark DB, Knatterud GL; Occluded Artery Trial Investigators. Coronary intervention for persistent occlusion after myocardial infarction. N Engl J Med. 2006 Dec 7;355(23):2395-407. doi: 10.1056/NEJMoa066139. Epub 2006 Nov 14.
- Udelson JE, Pearte CA, Kimmelstiel CD, Kruk M, Kufera JA, Forman SA, Teresinska A, Bychowiec B, Marin-Neto JA, Hochtl T, Cohen EA, Caramori P, Busz-Papiez B, Adlbrecht C, Sadowski ZP, Ruzyllo W, Kinan DJ, Lamas GA, Hochman JS. The Occluded Artery Trial (OAT) Viability Ancillary Study (OAT-NUC): influence of infarct zone viability on left ventricular remodeling after percutaneous coronary intervention versus optimal medical therapy alone. Am Heart J. 2011 Mar;161(3):611-21. doi: 10.1016/j.ahj.2010.11.020.
- Bellenger NG, Yousef Z, Rajappan K, Marber MS, Pennell DJ. Infarct zone viability influences ventricular remodelling after late recanalisation of an occluded infarct related artery. Heart. 2005 Apr;91(4):478-83. doi: 10.1136/hrt.2004.034918.
- Selvanayagam JB, Kardos A, Francis JM, Wiesmann F, Petersen SE, Taggart DP, Neubauer S. Value of delayed-enhancement cardiovascular magnetic resonance imaging in predicting myocardial viability after surgical revascularization. Circulation. 2004 Sep 21;110(12):1535-41. doi: 10.1161/01.CIR.0000142045.22628.74. Epub 2004 Sep 7.
- Long-term effects of intravenous thrombolysis in acute myocardial infarction: final report of the GISSI study. Gruppo Italiano per lo Studio della Streptochi-nasi nell'Infarto Miocardico (GISSI). Lancet. 1987 Oct 17;2(8564):871-4.
- O'Neill W, Timmis GC, Bourdillon PD, Lai P, Ganghadarhan V, Walton J Jr, Ramos R, Laufer N, Gordon S, Schork MA, et al. A prospective randomized clinical trial of intracoronary streptokinase versus coronary angioplasty for acute myocardial infarction. N Engl J Med. 1986 Mar 27;314(13):812-8. doi: 10.1056/NEJM198603273141303.
- Sociedade Brasileira de Cardiologia. [IV Guidelines of Sociedade Brasileira de Cardiologia for Treatment of Acute Myocardial Infarction with ST-segment elevation]. Arq Bras Cardiol. 2009;93(6 Suppl 2):e179-264. No abstract available. Erratum In: Arq Bras Cardiol. 2010 Oct;95(4):553. Portuguese.
- Eagle KA, Goodman SG, Avezum A, Budaj A, Sullivan CM, Lopez-Sendon J; GRACE Investigators. Practice variation and missed opportunities for reperfusion in ST-segment-elevation myocardial infarction: findings from the Global Registry of Acute Coronary Events (GRACE). Lancet. 2002 Feb 2;359(9304):373-7. doi: 10.1016/S0140-6736(02)07595-5.
- Cohen M, Gensini GF, Maritz F, Gurfinkel EP, Huber K, Timerman A, Krzeminska-Pakula M, Santopinto J, Hecquet C, Vittori L; TETAMI Investigators. Prospective evaluation of clinical outcomes after acute ST-elevation myocardial infarction in patients who are ineligible for reperfusion therapy: preliminary results from the TETAMI registry and randomized trial. Circulation. 2003 Oct 21;108(16 Suppl 1):III14-21. doi: 10.1161/01.CIR.0000091832.74006.1C.
- Late Assessment of Thrombolytic Efficacy (LATE) study with alteplase 6-24 hours after onset of acute myocardial infarction. Lancet. 1993 Sep 25;342(8874):759-66.
- Yousef ZR, Marber MS. The open artery hypothesis: potential mechanisms of action. Prog Cardiovasc Dis. 2000 May-Jun;42(6):419-38.
- Yousef ZR, Redwood SR, Bucknall CA, Sulke AN, Marber MS. Late intervention after anterior myocardial infarction: effects on left ventricular size, function, quality of life, and exercise tolerance: results of the Open Artery Trial (TOAT Study). J Am Coll Cardiol. 2002 Sep 4;40(5):869-76. doi: 10.1016/s0735-1097(02)02058-2.
- Silva JC, Rochitte CE, Junior JS, Tsutsui J, Andrade J, Martinez EE, Moffa PJ, Menegheti JC, Kalil-Filho R, Ramires JF, Nicolau JC. Late coronary artery recanalization effects on left ventricular remodelling and contractility by magnetic resonance imaging. Eur Heart J. 2005 Jan;26(1):36-43. doi: 10.1093/eurheartj/ehi011. Epub 2004 Nov 29.
- Abbate A, Biondi-Zoccai GG, Appleton DL, Erne P, Schoenenberger AW, Lipinski MJ, Agostoni P, Sheiban I, Vetrovec GW. Survival and cardiac remodeling benefits in patients undergoing late percutaneous coronary intervention of the infarct-related artery: evidence from a meta-analysis of randomized controlled trials. J Am Coll Cardiol. 2008 Mar 4;51(9):956-64. doi: 10.1016/j.jacc.2007.11.062. Epub 2008 Feb 6.
- Sabate M. Revascularization of the infarct-related artery: never too late to do well. J Am Coll Cardiol. 2008 Mar 4;51(9):965-7. doi: 10.1016/j.jacc.2008.01.003. Epub 2008 Feb 5. No abstract available.
- Erne P, Schoenenberger AW, Burckhardt D, Zuber M, Kiowski W, Buser PT, Dubach P, Resink TJ, Pfisterer M. Effects of percutaneous coronary interventions in silent ischemia after myocardial infarction: the SWISSI II randomized controlled trial. JAMA. 2007 May 9;297(18):1985-91. doi: 10.1001/jama.297.18.1985.
- Allman KC, Shaw LJ, Hachamovitch R, Udelson JE. Myocardial viability testing and impact of revascularization on prognosis in patients with coronary artery disease and left ventricular dysfunction: a meta-analysis. J Am Coll Cardiol. 2002 Apr 3;39(7):1151-8. doi: 10.1016/s0735-1097(02)01726-6.
- Camici PG, Prasad SK, Rimoldi OE. Stunning, hibernation, and assessment of myocardial viability. Circulation. 2008 Jan 1;117(1):103-14. doi: 10.1161/CIRCULATIONAHA.107.702993. No abstract available.
- Romero J, Xue X, Gonzalez W, Garcia MJ. CMR imaging assessing viability in patients with chronic ventricular dysfunction due to coronary artery disease: a meta-analysis of prospective trials. JACC Cardiovasc Imaging. 2012 May;5(5):494-508. doi: 10.1016/j.jcmg.2012.02.009.
- Gerber BL, Rousseau MF, Ahn SA, le Polain de Waroux JB, Pouleur AC, Phlips T, Vancraeynest D, Pasquet A, Vanoverschelde JL. Prognostic value of myocardial viability by delayed-enhanced magnetic resonance in patients with coronary artery disease and low ejection fraction: impact of revascularization therapy. J Am Coll Cardiol. 2012 Feb 28;59(9):825-35. doi: 10.1016/j.jacc.2011.09.073.
- STATACorp. 2019. Stata Statistical Software: Release 16.0. College Station, Texas : Stata Corporation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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