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Trial · Interventional

CompletedPhase 3Registry data

COMBinAtion Therapy in Myocardial Infarction: The COMBAT-MI Trial

Short name COMBAT-MI

NCTNCT02404376 (opens ClinicalTrials.gov in a new tab)Other idCOMBAT-MI
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
378 participants (actual)
Sponsor
Hospital Universitari Vall d'Hebron Research Institute · Other
Design
Randomized · Double masking
Countries
1 country

Spain

Start
Mar 2016
Primary completion
Aug 2019
Completion
Jun 2020
First posted
31 Mar 2015 (estimated)
Last update posted
3 Nov 2020
Conditions
ST Elevation Acute Myocardial Infarction

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018201920202021
  1. Ph 3

    COMBAT-MI

    NCT02404376

    Mar 2016 to Jun 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Remote ischemic conditioning (RIC) and intravenous exenatide administered immediately before primary angioplasty have been found to limit infarct size in patients with STEMI (ST segment elevation myocardial infarction), but the reduction is limited. This study investigates whether a combination therapy including both therapies is more effective.

Interventions

  • ExenatideDrug
  • Remote Ischemic Conditioning (RIC)Other
  • PlaceboDrug

Arms4

  • Active comparator

    Remote Ischemic Conditioning

    Remote Ischemic Conditioning + placebo

  • Active comparator

    Combined treatment

    Remote Ischemic Conditioning + exenatide

  • Placebo comparator

    Placebo

    Sham Remote Ischemic Conditioning + placebo

  • Active comparator

    Exenatide

    Sham Remote Ischemic Conditioning + exenatide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Myocardial Infarct Size

    Time frame · 3-7 days after pPCI

    Registry description

    MI, measured by late gadolinium enhancement in CMRI 3-7 days after pPCI, and expressed as percent of left ventricular mass.

Secondary outcomes(6)

  1. Myocardial salvage index

    Time frame · 3-7 days after pPCI

    Registry description

    Myocardial salvage index defined as the difference between infarct size and area at risk, defined by the T2 CMRI and expressed as a percent of total LV (Left Ventricular) mass, divided by the area at risk.

  2. Transmurality index

    Time frame · 3-7 days after pPCI

    Registry description

    Transmurality index, defined as the ratio of the mass of myocardium showing late gadolinium enhancement to the mass of the myocardial segment containing it.

  3. Ventricular volumes

    Time frame · 3-7 days after pPCI

    Registry description

    LV (Left Ventricular) end-diastolic volume and LVEF (Left Ventricular Ejection Fraction), as determined by CMRI.

  4. Microvascular obstruction

    Time frame · 3-7 days after pPCI

    Registry description

    Volume of myocardium with microvascular obstruction determined by late gadolinium enhancement expressed as percent of infarct size.

  5. Markers of successful reperfusion

    Time frame · First 90 min after reperfusion

    Registry description

    Markers of successful myocardial reperfusion: ST segment resolution 90 minutes post-pPCI , TIMI flow and frame-count post-pPCI , and TIMI blush grade .

  6. Major adverse cardiac events (MACE)

    Time frame · Hospital discharge and expected average of 1 week, one year follow-up

    Registry description

    MACE rate during hospitalization, defined as death, non-fatal myocardial rupture, or appearance or worsening of heart failure during the hospitalization period and after 1 year of follow-up

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

8 results

Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction.

Lønborg et al. 2012European heart journalcited by 421

PMID 21920963DOI 10.1093/eurheartj/ehr309PUB-21920963

Rights unknown8 results
Source linkSee results (8)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultBotker HE, Kharbanda R, Schmidt MR, Bottcher M, Kaltoft AK, Terkelsen CJ, Munk K, Andersen NH, Hansen TM, Trautner S, Lassen JF, Christiansen EH, Krusell LR, Kristensen SD, Thuesen L, Nielsen SS, Rehling M, Sorensen HT, Redington AN, Nielsen TT. Remote ischaemic conditioning before hospital admission, as a complement to angioplasty, and effect on myocardial salvage in patients with acute myocardial infarction: a randomised trial. Lancet. 2010 Feb 27;375(9716):727-34. doi: 10.1016/S0140-6736(09)62001-8. PMID 20189026
  • ResultWhite SK, Frohlich GM, Sado DM, Maestrini V, Fontana M, Treibel TA, Tehrani S, Flett AS, Meier P, Ariti C, Davies JR, Moon JC, Yellon DM, Hausenloy DJ. Remote ischemic conditioning reduces myocardial infarct size and edema in patients with ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt B):178-188. doi: 10.1016/j.jcin.2014.05.015. Epub 2014 Sep 17. PMID 25240548
  • ResultGarcia-Dorado D, Garcia-del-Blanco B, Otaegui I, Rodriguez-Palomares J, Pineda V, Gimeno F, Ruiz-Salmeron R, Elizaga J, Evangelista A, Fernandez-Aviles F, San-Roman A, Ferreira-Gonzalez I. Intracoronary injection of adenosine before reperfusion in patients with ST-segment elevation myocardial infarction: a randomized controlled clinical trial. Int J Cardiol. 2014 Dec 20;177(3):935-41. doi: 10.1016/j.ijcard.2014.09.203. Epub 2014 Oct 7. PMID 25449504
  • DerivedConsegal M, Barba I, Garcia Del Blanco B, Otaegui I, Rodriguez-Palomares JF, Marti G, Serra B, Bellera N, Ojeda-Ramos M, Valente F, Carmona MA, Miro-Casas E, Sambola A, Lidon RM, Baneras J, Barrabes JA, Rodriguez C, Benito B, Ruiz-Meana M, Inserte J, Ferreira-Gonzalez I, Rodriguez-Sinovas A. Spontaneous reperfusion enhances succinate concentration in peripheral blood from stemi patients but its levels does not correlate with myocardial infarct size or area at risk. Sci Rep. 2023 Apr 27;13(1):6907. doi: 10.1038/s41598-023-34196-7. PMID 37106099

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Men or women ≥18 years of age * STEMI characterized by 2 mm ST segment elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with minimum of 1 mm concordant ST elevation or 1 mV(millivolt) ST segment elevation in the limb leads (II, III and aVF leads, I, aVL leads) and V4-V6. * Patients presenting within 6 hours of chest pain. Exclusion Criteria: * Known hypersensitivity to exenatide or any of the excipients * Known contraindication to CMR imaging such as significant claustrophobia, severe allergy to gadolinium chelate contrast, severe renal insufficiency (defined as estimated glomerular filtration rate \[eGFR\] (epidermal growth factor receptor) \<30 mL/min/1.73 m2), presence of CMRI contraindicated implanted devices (e.g., pacemaker, implanted cardiac defibrillator, cardiac resynchronization therapy device, cochlear implant), embedded metal objects (e.g., shrapnel), or any other contraindication for CMRI. * Assumed life expectancy \< 1 year e.g. due to non-cardiac disease. * TIMI flow grade \> 1 at the time of diagnostic coronary angiography. These patients will be excluded from the analysis of infarct size but will be included in the safety analysis. * Pregnant women * Patients with loss of consciousness or confused, not able to read the information and to sign the writting consent * Patients with oro-tracheal intubation * Patients with cardiogenic shock persisting 48h after reperfusion

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