ST Elevation Acute Myocardial InfarctionPhase 3COMBAT-MINCT02404376
COMBinAtion Therapy in Myocardial Infarction: The COMBAT-MI Trial
A Phase 3 study testing Exenatide and Remote Ischemic Conditioning (RIC) in people with ST Elevation Acute Myocardial Infarction, run by Hospital Universitari Vall d'Hebron Research Institute at 6 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Acute Myocardial Infarction
- What is being tested?
- Exenatide and Remote Ischemic Conditioning (RIC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 378 participants
- Where
- 6 sitesSpain
- Study dates
- Mar 2016to Jun 2020
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Universitario Valle de Hebron
Barcelona, 08035
Hospital Universitario Arnau de Vilanova
Lleida, 25198
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, La Coruña, 15706
Hospital Universitari de Tarragona Joan 23
Tarragona, 43005
About this study
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.
Read the detailed description
COMBAT-MI is an investigator-driven, randomized, double-blind and placebo-controlled clinical trial aimed at evaluating the effect of Remote Ischemic Conditioning and exenatide, alone and in combination, on Myocardial Infarct size in 428 STEMI patients (107 per group) (ST segment elevation myocardial infarction). Patients with TIMI (Thrombolysis in Myocardial Infarction) flow grade > 1 will be excluded. The study has a 2 x 2 factorial design (Remote Ischemic Conditioning , Exenatide, both or neither). The primary end-point will be Myocardial Infarct size measured by Cardiac Magnetic Resonance Imaging (CMRI) performed 3 - 7 days after primary Percutaneous Coronary Intervention (pPCI) (expressed as % of left ventricular (LV) mass). Sample size has been calculated in 274 patients with TIMI 0-1 available for analysis of the primary end-point, and inclusion will end when this number is reached, which will require, according to the current rate of TIMI 0-1 in our STEMI population, to randomize 428 patients. Secondary end-points will include myocardial salvage index, based on angiographic and CMRI derived estimations of the area at risk, and frequency of Major Adverse Cardiovascular Events (MACE) and of major adverse events during admission.
- Conditions
- ST Elevation Acute Myocardial Infarction
- Being tested
- Exenatide, Remote Ischemic Conditioning (RIC), Placebo
- Keywords
- STEMI, Reperfusion Injury, Myocardial Infarction, Myocardial Ischemia, Remote Ischemic Conditioning, Exenatide, Glucagon-Like Peptide-1 (GLP-1), Acute Coronary Syndrome, Cardioprotection
- Medical subject headings
- ST Elevation Myocardial Infarction, Reperfusion Injury, Myocardial Infarction, Myocardial Ischemia, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Intravenous administration of Exenatide
Remote Ischemic Conditioning (RIC)Other
Remote ischemic conditioning with a cuff in the arm
PlaceboDrug
Intrevenous administration of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Conditioning | Active comparator | Remote Ischemic Conditioning + placebo Receives: Other: Remote Ischemic Conditioning (RIC); Drug: Placebo |
| Combined treatment | Active comparator | Remote Ischemic Conditioning + exenatide Receives: Drug: Exenatide; Other: Remote Ischemic Conditioning (RIC) |
| Placebo | Placebo comparator | Sham Remote Ischemic Conditioning + placebo Receives: Other: Remote Ischemic Conditioning (RIC); Drug: Placebo |
| Exenatide | Active comparator | Sham Remote Ischemic Conditioning + exenatide Receives: Drug: Exenatide; Other: Remote Ischemic Conditioning (RIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Infarct Size
MI, measured by late gadolinium enhancement in CMRI 3-7 days after pPCI, and expressed as percent of left ventricular mass.
Measured: 3-7 days after pPCI
Secondary outcomes (6)
Myocardial salvage index
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.
Measured: 3-7 days after pPCI
Transmurality index
Transmurality index, defined as the ratio of the mass of myocardium showing late gadolinium enhancement to the mass of the myocardial segment containing it.
Measured: 3-7 days after pPCI
Ventricular volumes
LV (Left Ventricular) end-diastolic volume and LVEF (Left Ventricular Ejection Fraction), as determined by CMRI.
Measured: 3-7 days after pPCI
Microvascular obstruction
Volume of myocardium with microvascular obstruction determined by late gadolinium enhancement expressed as percent of infarct size.
Measured: 3-7 days after pPCI
Markers of successful reperfusion
Markers of successful myocardial reperfusion: ST segment resolution 90 minutes post-pPCI , TIMI flow and frame-count post-pPCI , and TIMI blush grade .
Measured: First 90 min after reperfusion
Major adverse cardiac events (MACE)
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
Measured: Hospital discharge and expected average of 1 week, one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startMar 2016
- Primary completionAug 2019
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ignacio Ferreira González, MD, PhD, Principal investigator, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404376
- Sponsor's protocol ID
- COMBAT-MI
- Acronym
- COMBAT-MI
- Status last verified
- Feb 2020
- First submitted
- 20 Mar 2015
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21920963Botker 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.
PubMed 20189026White 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.
PubMed 25240548Garcia-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.
PubMed 25449504Consegal 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.
PubMed 37106099
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMBinAtion Therapy in Myocardial Infarction: The COMBAT-MI Trial
- ClinicalTrials.gov ID
- NCT02404376
- Acronym / sponsor ID
- COMBAT-MI / COMBAT-MI
- Conditions
- ST Elevation Acute Myocardial Infarction
- Keywords
- STEMI, Reperfusion Injury, Myocardial Infarction, Myocardial Ischemia, Remote Ischemic Conditioning, Exenatide, Glucagon-Like Peptide-1 (GLP-1), Acute Coronary Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
COMBAT-MI is an investigator-driven, randomized, double-blind and placebo-controlled clinical trial aimed at evaluating the effect of Remote Ischemic Conditioning and exenatide, alone and in combination, on Myocardial Infarct size in 428 STEMI patients (107 per group) (ST segment elevation myocardial infarction). Patients with TIMI (Thrombolysis in Myocardial Infarction) flow grade > 1 will be excluded. The study has a 2 x 2 factorial design (Remote Ischemic Conditioning , Exenatide, both or neither). The primary end-point will be Myocardial Infarct size measured by Cardiac Magnetic Resonance Imaging (CMRI) performed 3 - 7 days after primary Percutaneous Coronary Intervention (pPCI) (expressed as % of left ventricular (LV) mass). Sample size has been calculated in 274 patients with TIMI 0-1 available for analysis of the primary end-point, and inclusion will end when this number is reached, which will require, according to the current rate of TIMI 0-1 in our STEMI population, to randomize 428 patients. Secondary end-points will include myocardial salvage index, based on angiographic and CMRI derived estimations of the area at risk, and frequency of Major Adverse Cardiovascular Events (MACE) and of major adverse events during admission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Conditioning | Active comparator | Other: Remote Ischemic Conditioning (RIC), Drug: PlaceboRemote Ischemic Conditioning + placebo |
| Combined treatment | Active comparator | Drug: Exenatide, Other: Remote Ischemic Conditioning (RIC)Remote Ischemic Conditioning + exenatide |
| Placebo | Placebo comparator | Other: Remote Ischemic Conditioning (RIC), Drug: PlaceboSham Remote Ischemic Conditioning + placebo |
| Exenatide | Active comparator | Drug: Exenatide, Other: Remote Ischemic Conditioning (RIC)Sham Remote Ischemic Conditioning + exenatide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExenatideIntravenous administration of Exenatide | Drug | Combined treatment, Exenatide |
| Remote Ischemic Conditioning (RIC)Remote ischemic conditioning with a cuff in the arm | Other | Combined treatment, Exenatide, Placebo, Remote Ischemic Conditioning |
| PlaceboIntrevenous administration of Placebo | Drug | Placebo, Remote Ischemic Conditioning |
Primary outcome
Myocardial Infarct Size
Time frame: 3-7 days after pPCI
MI, measured by late gadolinium enhancement in CMRI 3-7 days after pPCI, and expressed as percent of left ventricular mass.
6 secondary outcomes
Myocardial salvage index
Time frame: 3-7 days after pPCI
Transmurality index
Time frame: 3-7 days after pPCI
Ventricular volumes
Time frame: 3-7 days after pPCI
Microvascular obstruction
Time frame: 3-7 days after pPCI
Markers of successful reperfusion
Time frame: First 90 min after reperfusion
Major adverse cardiac events (MACE)
Time frame: Hospital discharge and expected average of 1 week, one year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Background: PubMed 21920963Lonborg 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.
- Results publication: PubMed 20189026Botker 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.
- Results publication: PubMed 25240548White 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.
- Results publication: PubMed 25449504Garcia-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.
- Derived from this study: PubMed 37106099Consegal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignacio Ferreira González, MD, PhD principal investigator
Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exenatide and Remote Ischemic Conditioning (RIC) in people with ST Elevation Acute Myocardial Infarction, run by Hospital Universitari Vall d'Hebron Research Institute at 6 sites in Spain.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial Infarct Size (time frame: 3-7 days after pPCI). 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 NCT02404376, which also lists 5 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 3 Nov 2020.