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STEMI - ST Elevation Myocardial InfarctionNCT05160311

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

A study testing Optimized Medical Treatment (OMT) and Drug Eluting Stent (DES) Coronary Angioplasty in people with STEMI - ST Elevation Myocardial Infarction and Myocardial Dysfunction, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Optimized Medical Treatment (OMT) and Drug Eluting Stent (DES) Coronary Angioplasty
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteBrazil
Study dates
1 Aug 2021to 1 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 25Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Barbara Valente, MD contact

5585988083444

barbaravalente@hotmail.com

Pedro Farsky, MD, PhD contact

5511991662309

pedro.farsky@gmail.com

Brazil1 site, 1 recruiting

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, 04012909

    BARBARA VALENTE, MD, 551150856204, BARBARAVALENTE@HOTMAIL.COM

    RENATA VIANA, MD, 551150856204, RVIANA@DANTEPAZZANESE.ORG.BR

    Recruiting

Other trials in Brazil

About this study

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.

Read the 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.

Being tested
Optimized Medical Treatment (OMT), Drug Eluting Stent (DES) Coronary Angioplasty
Keywords
STEMI, myocardial viability, Late percutaneous coronary intervention, myocardial remodelling, Myocardial reperfusion
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optimized Medical Treatment (OMT)Drug

    Optimized Medical Drug Treatment

  • Drug Eluting Stent (DES) Coronary AngioplastyDevice

    Percutaneous Angioplasty with DES

Study groups in NCT05160311
Study groupRoleWhat they receive
Optimized Medical Treatment (OMT)OtherThe 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)
Receives: Drug: Optimized Medical Treatment (OMT)
Angioplasty (PCI) and Optimized Medical Treatment (OMT)ExperimentalThe patient considered non-viable and randomized to Coronary Angioplasty will be treated with drug-eluting stent (PCI) and Optimized Medical Treatment (OMT)
Receives: Drug: Optimized Medical Treatment (OMT); Device: Drug Eluting Stent (DES) Coronary Angioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

Secondary outcomes (8)

  1. 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.

    Measured: 6 months

  2. Assessement of Myocardial contractility

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

    Measured: 6 months

  3. 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.

    Measured: 6 months

  4. Acute MI Event

    Incidence of Acute Myocardial Infarct.

    Measured: 6 months

  5. Unplanned revascularization (Ischemia Driven and Not Ischemia Driven)

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

    Measured: 6 months

  6. 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).

    Measured: 6 months

  7. Cardiovascular-Related Hospitalization

    Incidence of New Cardiovascular related Hospitalization after discharge

    Measured: 6 months

  8. 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).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2021
  2. Study start1 Aug 2021
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05160311
Sponsor's protocol ID
5106
Status last verified
Dec 2021
First submitted
29 Oct 2021
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 2889079

  • 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.

    PubMed 2936956

  • 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.

  • 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.

    PubMed 28886621

  • 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.

    PubMed 11844506

  • 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.

    PubMed 14605015

  • 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.

    PubMed 8103874

  • 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.

    PubMed 8184807

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

    PubMed 10871164

  • 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.

    PubMed 9832481

  • 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.

    PubMed 12225709

  • 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.

    PubMed 15615797

  • 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.

    PubMed 17105759

  • 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.

    PubMed 18308165

  • 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.

    PubMed 18308166

Questions about this trial

What is this clinical trial studying?

A study testing Optimized Medical Treatment (OMT) and Drug Eluting Stent (DES) Coronary Angioplasty in people with STEMI - ST Elevation Myocardial Infarction and Myocardial Dysfunction, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Barbara Valente, MD (5585988083444, barbaravalente@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reverse myocardial remodeling after late recanalization in patients without viability (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05160311, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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