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Percutaneous Revascularization in Infarction With Late Presentation and Absence of Viability: Effects on Left Ventricular Remodeling and Contractility

Primary Purpose

STEMI - ST Elevation Myocardial Infarction, Myocardial Dysfunction, Percutaneous Coronary Intervention

Status

Recruiting

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Optimized Medical Treatment (OMT)

Drug Eluting Stent (DES) Coronary Angioplasty

About this trial

This is an interventional treatment trial for STEMI - ST Elevation Myocardial Infarction focused on measuring STEMI, myocardial viability, Late percutaneous coronary intervention, myocardial remodelling, Myocardial reperfusion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Instituto Dante Pazzanese de CardiologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Optimized Medical Treatment (OMT)

Angioplasty (PCI) and Optimized Medical Treatment (OMT)

Arm Description

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)

The patient considered non-viable and randomized to Coronary Angioplasty will be treated with drug-eluting stent (PCI) and Optimized Medical Treatment (OMT)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Assessement of Myocardial contractility

Evaluate the change of reverse LV remodeling after late recanalization assessed by MRI.

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.

Acute MI Event

Incidence of Acute Myocardial Infarct.

Unplanned revascularization (Ischemia Driven and Not Ischemia Driven)

Incidence of Unplanned Myocardial revascularization (Ischemia Driven and Not Ischemia Driven) after hospital discharge

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).

Cardiovascular-Related Hospitalization

Incidence of New Cardiovascular related Hospitalization after discharge

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).

Full Information

NCT ID

NCT05160311

First Posted

October 29, 2021

Last Updated

December 22, 2021

Sponsor

Instituto Dante Pazzanese de Cardiologia

1. Study Identification

Unique Protocol Identification Number

NCT05160311

Brief Title

Percutaneous Revascularization in Infarction With Late Presentation and Absence of Viability: Effects on Left Ventricular Remodeling and Contractility

Official Title

Percutaneous Revascularization in Infarction With Late Presentation and Absence of Viability: Effects on Left Ventricular Remodeling and Contractility

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Instituto Dante Pazzanese de Cardiologia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

STEMI - ST Elevation Myocardial Infarction, Myocardial Dysfunction, Percutaneous Coronary Intervention

Keywords

STEMI, myocardial viability, Late percutaneous coronary intervention, myocardial remodelling, Myocardial reperfusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Optimized Medical Treatment (OMT)

Arm Type

Other

Arm Description

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)

Arm Title

Angioplasty (PCI) and Optimized Medical Treatment (OMT)

Arm Type

Experimental

Arm Description

The patient considered non-viable and randomized to Coronary Angioplasty will be treated with drug-eluting stent (PCI) and Optimized Medical Treatment (OMT)

Intervention Type

Drug

Intervention Name(s)

Optimized Medical Treatment (OMT)

Intervention Description

Optimized Medical Drug Treatment

Intervention Type

Device

Intervention Name(s)

Drug Eluting Stent (DES) Coronary Angioplasty

Intervention Description

Percutaneous Angioplasty with DES

Primary Outcome Measure Information:

Title

Reverse myocardial remodeling after late recanalization in patients without viability

Description

Evaluate reverse remodeling after late recanalization in patients without viability measuring End Systolic Volume (ESV) by MRI

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Assessement of Left Ventricle Ejection Fraction (LVEF)

Description

Time Frame

6 months

Title

Assessement of Myocardial contractility

Description

Evaluate the change of reverse LV remodeling after late recanalization assessed by MRI.

Time Frame

6 months

Title

Evaluate Quality of Life

Description

Time Frame

6 months

Title

Acute MI Event

Description

Incidence of Acute Myocardial Infarct.

Time Frame

6 months

Title

Unplanned revascularization (Ischemia Driven and Not Ischemia Driven)

Description

Incidence of Unplanned Myocardial revascularization (Ischemia Driven and Not Ischemia Driven) after hospital discharge

Time Frame

6 months

Title

Cardiovascular Death

Description

Time Frame

6 months

Title

Cardiovascular-Related Hospitalization

Description

Incidence of New Cardiovascular related Hospitalization after discharge

Time Frame

6 months

Title

Stroke Event

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Barbara Valente, MD

Phone

5585988083444

barbaravalente@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Pedro Farsky, MD, PhD

Phone

5511991662309

pedro.farsky@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara Valente, MD

Organizational Affiliation

Instituto Dante Pazzanese de Cardiologia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto Dante Pazzanese de Cardiologia

City

Sao Paulo

ZIP/Postal Code

04012909

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

BARBARA VALENTE, MD

Phone

551150856204

BARBARAVALENTE@HOTMAIL.COM

First Name & Middle Initial & Last Name & Degree

RENATA VIANA, MD

Phone

551150856204

RVIANA@DANTEPAZZANESE.ORG.BR

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

2889079

Citation

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.

Results Reference

background

PubMed Identifier

2936956

Citation

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.

Results Reference

background

Citation

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.

Results Reference

background

PubMed Identifier

28886621

Citation

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.

Results Reference

background

PubMed Identifier

11844506

Citation

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.

Results Reference

background

PubMed Identifier

14605015

Citation

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.

Results Reference

background

PubMed Identifier

8103874

Citation

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.

Results Reference

background

PubMed Identifier

8184807

Citation

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.

Results Reference

background

PubMed Identifier

10871164

Citation

Yousef ZR, Marber MS. The open artery hypothesis: potential mechanisms of action. Prog Cardiovasc Dis. 2000 May-Jun;42(6):419-38.

Results Reference

background

PubMed Identifier

9832481

Citation

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.

Results Reference

background

PubMed Identifier

12225709

Citation

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.

Results Reference

background

PubMed Identifier

15615797

Citation

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.

Results Reference

background

PubMed Identifier

17105759

Citation

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.

Results Reference

background

PubMed Identifier

18308165

Citation

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.

Results Reference

background

PubMed Identifier

18308166

Citation

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.

Results Reference

background

PubMed Identifier

17488963

Citation

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.

Results Reference

background

PubMed Identifier

11923039

Citation

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.

Results Reference

background

PubMed Identifier

21392619

Citation

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.

Results Reference

background

PubMed Identifier

15772205

Citation

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.

Results Reference

background

PubMed Identifier

11078769

Citation

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.

Results Reference

background

PubMed Identifier

15353496

Citation

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.

Results Reference

background

PubMed Identifier

18172050

Citation

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.

Results Reference

background

PubMed Identifier

22595157

Citation

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.

Results Reference

background

PubMed Identifier

22361403

Citation

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.

Results Reference

background

Citation

STATACorp. 2019. Stata Statistical Software: Release 16.0. College Station, Texas : Stata Corporation

Results Reference

background

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Percutaneous Revascularization in Infarction With Late Presentation and Absence of Viability: Effects on Left Ventricular Remodeling and Contractility

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