COMBinAtion Therapy in Myocardial Infarction: The COMBAT-MI Trial
COMBAT-MI
1 other identifier
interventional
378
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2016
Typical duration for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedNovember 3, 2020
February 1, 2020
3.4 years
March 20, 2015
November 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myocardial Infarct Size
MI, measured by late gadolinium enhancement in CMRI 3-7 days after pPCI, and expressed as percent of left ventricular mass.
3-7 days after pPCI
Secondary Outcomes (6)
Myocardial salvage index
3-7 days after pPCI
Transmurality index
3-7 days after pPCI
Ventricular volumes
3-7 days after pPCI
Microvascular obstruction
3-7 days after pPCI
Markers of successful reperfusion
First 90 min after reperfusion
- +1 more secondary outcomes
Other Outcomes (2)
Substudy: Biomarker analysis in Hospital Universitari Vall d'Hebron Biobank (HUVH Biobank)
pre- pPCI
PRESPECIFIED SUBGROUP ANALYSIS ACCORDING TO TOTAL ISCHEMIC TIME
3-7 days after pPCI
Study Arms (4)
Remote Ischemic Conditioning
ACTIVE COMPARATORRemote Ischemic Conditioning + placebo
Combined treatment
ACTIVE COMPARATORRemote Ischemic Conditioning + exenatide
Placebo
PLACEBO COMPARATORSham Remote Ischemic Conditioning + placebo
Exenatide
ACTIVE COMPARATORSham Remote Ischemic Conditioning + exenatide
Interventions
Remote ischemic conditioning with a cuff in the arm
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, La Coruña, 15706, Spain
Hospital Universitario Valle de Hebron
Barcelona, 08035, Spain
Hospital Universitario Arnau de Vilanova
Lleida, 25198, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitari de Tarragona Joan 23
Tarragona, 43005, Spain
Related Publications (5)
Lonborg J, Vejlstrup N, Kelbaek H, Botker HE, Kim WY, Mathiasen AB, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Holmvang L, Thuesen L, Krusell LR, Jensen JS, Kober L, Treiman M, Holst JJ, Engstrom T. Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction. Eur Heart J. 2012 Jun;33(12):1491-9. doi: 10.1093/eurheartj/ehr309. Epub 2011 Sep 14.
PMID: 21920963BACKGROUNDBotker 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: 20189026RESULTWhite 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: 25240548RESULTGarcia-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: 25449504RESULTConsegal 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: 37106099DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ignacio Ferreira González, MD, PhD
Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2015
First Posted
March 31, 2015
Study Start
March 1, 2016
Primary Completion
August 1, 2019
Study Completion
June 1, 2020
Last Updated
November 3, 2020
Record last verified: 2020-02