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The purpose of this study is to evaluate whether late recanalization in patients with ST elevation myocardial infarction (STEMI) without Viability on Cardiovascular Magnetic Resonance Image (MRI) can reduce the reverse remodeling through the reduction of the End Systolic Volume (ESV) at 6 months.
The purpose of this study is to evaluate whether late recanalization in patients with ST elevation myocardial infarction (STEMI) without Viability on Cardiovascular Magnetic Resonance can reduce the reverse remodeling through the reduction of the End Systolic Volume (ESV) at 6 months and through the improvement in segmental contractility of infarcted related artery at MRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimized Medical Treatment (OMT) | Other | 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) |
|
| Angioplasty (PCI) and Optimized Medical Treatment (OMT) | Experimental | The patient considered non-viable and randomized to Coronary Angioplasty will be treated with drug-eluting stent (PCI) and Optimized Medical Treatment (OMT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimized Medical Treatment (OMT) | Drug | Optimized Medical Drug Treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reverse myocardial remodeling after late recanalization in patients without viability | Evaluate reverse remodeling after late recanalization in patients without viability measuring End Systolic Volume (ESV) by MRI | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessement of Left Ventricle Ejection Fraction (LVEF) | 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 |
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Inclusion Criteria
3.3 Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara Valente, MD | Contact | 5585988083444 | barbaravalente@hotmail.com | |
| Pedro Farsky, MD, PhD | Contact | 5511991662309 | pedro.farsky@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Barbara Valente, MD | Instituto Dante Pazzanese de Cardiologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Dante Pazzanese de Cardiologia | Recruiting | São Paulo | 04012909 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2889079 | Background | 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. | |
| 2936956 | Background | 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. |
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Patients who had underestimated STEMI with more than 24 hours up to 28 days referred by the Cross System (Central For Regulation of Health Services Supply) and the Campo Limpo Hospital (Co-participant Center) will be admitted sequentially for coronary angiography in the hemodynamics sector of the Instituto Dante Pazzanese de Cardiologia (IDPC) from August 2021 to February 2023.
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| Drug Eluting Stent (DES) Coronary Angioplasty | Device | Percutaneous Angioplasty with DES |
|
Evaluate the change of reverse LV remodeling after late recanalization assessed by MRI. |
| 6 months |
| Evaluate Quality of Life | 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 | Incidence of Acute Myocardial Infarct. | 6 months |
| Unplanned revascularization (Ischemia Driven and Not Ischemia Driven) | Incidence of Unplanned Myocardial revascularization (Ischemia Driven and Not Ischemia Driven) after hospital discharge | 6 months |
| Cardiovascular Death | 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 | Incidence of New Cardiovascular related Hospitalization after discharge | 6 months |
| Stroke Event | 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 |
| Background | Piegas LS, Feitosa G, Mattos LA, Nicolau JC, Rossi Neto JM et al. Brazilian Society of Cardiology. IV Guideline of the Brazilian Society of Cardiology on The Treatment of Acute Myocardial Infarction with ST Segment Supradeslevel. Arq Bras Cardiol.2009;93(6 supl.2):e179-e264. |
| 28886621 | Background | 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. |
| 11844506 | Background | 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. |
| 14605015 | Background | 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. |
| 8103874 | Background | 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. |
| 8184807 | Background | 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. |
| 10871164 | Background | Yousef ZR, Marber MS. The open artery hypothesis: potential mechanisms of action. Prog Cardiovasc Dis. 2000 May-Jun;42(6):419-38. |
| 9832481 | Background | 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. |
| 12225709 | Background | 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. |
| 15615797 | Background | 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. |
| 17105759 | Background | 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. |
| 18308165 | Background | 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. |
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| 15353496 | Background | 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. |
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| Background | STATACorp. 2019. Stata Statistical Software: Release 16.0. College Station, Texas : Stata Corporation |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| D000800 | Angioplasty, Balloon |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
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