Myocardial Infarction, AcuteCARIOCANCT03155022
Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction
A study testing Remote ischemic conditioning and intracoronary ischemic conditioning and Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning in people with Myocardial Infarction, Acute, run by Hospices Civils de Lyon at 4 sites in 2 countries.
Trial summary
Infarct size is a major determinant of prognosis after AMI. Evidence indicates that the combination of intracoronary ischemic conditioning (ICIC) and remote ischemic conditioning (RIC) can significantly reduce infarct size in STEMI patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Acute
- What is being tested?
- Remote ischemic conditioning and intracoronary ischemic conditioning and Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 12 Apr 2018to 3 Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All (male and female) patients, aged over 18,
- Presenting within 12 hours of the onset of chest pain,
- For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI),
- ST segment elevation ≥ 0.2 mV in two contiguous ECG leads,
- Written informed consent obtained or oral informed consent certified by a third party.
- Non inclusion Criteria:
Show all 12Show fewer
- Patients with cardiogenic shock,
- Patients with uncontrolled (treated or untreated) hypertension (> 180/110 mmHg),
- Patients with loss of consciousness or confused,
- Patients without health coverage,
- Patient with any legal protection measure,
- Female patients currently pregnant (oral diagnosis) or women of childbearing age who were not using contraception.
Who cannot join
- Patients with main occlusion localized on :
- LAD: distal or ostial segment,
- Non dominant RCA / CX: mid or distal segment,
- Dominant RCA / CX: distal segment,
- Any other arteries apart LAD/CX/RCA; Patients with evidence of coronary collaterals to the risk region (Rentrop score ≥ 2); Patients with an opened (TIMI > 1) culprit coronary artery on initial admission coronary angiography or a failed PCI (final TIMI=0).
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Belgium3 sites
Algemeen Ziekenhuis Sint Jan
Bruges
CHU de Charleroi
Charleroi
Universitair Ziekenhuis Antwerpen
Edegem
About this study
Official title: Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction: A Multicenter, Randomized, Controlled Clinical Trial (CARIOCA Study)
Infarct size is a major determinant of prognosis after AMI. Evidence indicates that the combination of intracoronary ischemic conditioning (ICIC) and remote ischemic conditioning (RIC) can significantly reduce infarct size in STEMI patients. Whether the combination of these two interventions may improve clinical outcome after STEMI remains unknown. The objective of the present study is to determine whether combination of ICIC and RIC can improve STEMI patients clinical outcome at 6 months.
- Conditions
- Myocardial Infarction, Acute
- Being tested
- Remote ischemic conditioning and intracoronary ischemic conditioning, Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning
- Keywords
- ST-elevation myocardial infarction
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioning and intracoronary ischemic conditioningDevice
RIC: Four cycles of [5 min brachial cuff inflation at 200 mmHg followed by 5 min of cuff deflation] started as soon as possible prior to PCI reperfusion. At least one full cycle (inflation + deflation) has to be completed before PCI reperfusion.
ICIC: Four cycles of [1 min balloon inflation followed by 1 min balloon deflation] started as soon as possible after reopening of the culprit coronary artery (maximum within 3 minutes after reflow). The balloon will be placed carefully above the culprit lesion so as to minimize potential micro-embolization.
Patients with no remote ischemic conditioning and no intracoronary ischemic conditioningDevice
Brachial cuff is positioned during 40 minutes but not inflated. No intracoronary balloon inflation.
| Study group | Role | What they receive |
|---|---|---|
| RIC+ ICIC + | Experimental | Patients with remote ischemic conditioning and intracoronary ischemic conditioning Receives: Device: Remote ischemic conditioning and intracoronary ischemic conditioning |
| RCI - ICIC - | Other | Control group with no remote ischemic conditioning and no intracoronary ischemic conditioning Receives: Device: Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined incidence of [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months after MI, large infarct defined as CK peak at 6 hours > 4500 UI/L]
Measured: 6 months
Secondary outcomes (9)
Cardiovascular death at 6 months.
Measured: 6 months
Worsening of heart failure
Worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months.
Measured: 6 months
Time to first event [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure]
Measured: 6 months
Major Adverse Cardiac Events (MACE)
MACE at 6 months: [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure; malignant ventricular arrhythmias; recurrent infarction; unstable angina; unplanned revascularization; stroke].
Measured: 6 months
Renal failure
Renal failure (+25% increase in serum creatinine at 6 months versus baseline).
Measured: 6 months
Peak of creatine kinase
Measured: 4-6 hours post-PCI
creatine kinase
Measured: 5 days
Measure hsCRP
Measured: 5 days
Rate of CRP
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start12 Apr 2018
- Primary completion3 Oct 2023
- Study completion3 Oct 2023
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction, AcuteStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Rioufol, Pr, Principal investigator, Hôpital Louis Pradel 28 avenue Doyen Lépine, BP Lyon-Montchat, 69394LYON cedex 03
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155022
- Sponsor's protocol ID
- 69HCL17_0032
- Other IDs
- 2017-A01683-50
- Acronym
- CARIOCA
- Status last verified
- May 2026
- First submitted
- 11 May 2017
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction: A Multicenter, Randomized, Controlled Clinical Trial (CARIOCA Study)
- ClinicalTrials.gov ID
- NCT03155022
- Acronym / sponsor ID
- CARIOCA / 69HCL17_0032
- Conditions
- Myocardial Infarction, Acute
- Keywords
- ST-elevation myocardial infarction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 16 May 2017 (actual)
- 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.
Infarct size is a major determinant of prognosis after AMI. Evidence indicates that the combination of intracoronary ischemic conditioning (ICIC) and remote ischemic conditioning (RIC) can significantly reduce infarct size in STEMI patients. Whether the combination of these two interventions may improve clinical outcome after STEMI remains unknown. The objective of the present study is to determine whether combination of ICIC and RIC can improve STEMI patients clinical outcome at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC+ ICIC + | Experimental | Device: Remote ischemic conditioning and intracoronary ischemic conditioningPatients with remote ischemic conditioning and intracoronary ischemic conditioning |
| RCI - ICIC - | Other | Device: Patients with no remote ischemic conditioning and no intracoronary ischemic conditioningControl group with no remote ischemic conditioning and no intracoronary ischemic conditioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- All (male and female) patients, aged over 18,
- Presenting within 12 hours of the onset of chest pain,
- For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI),
- ST segment elevation ≥ 0.2 mV in two contiguous ECG leads,
- Written informed consent obtained or oral informed consent certified by a third party.
Key exclusion criteria (5 listed)
- LAD: distal or ostial segment,
- Non dominant RCA / CX: mid or distal segment,
- Dominant RCA / CX: distal segment,
- Any other arteries apart LAD/CX/RCA; Patients with evidence of coronary collaterals to the risk region (Rentrop score ≥ 2); Patients with an opened (TIMI > 1) culprit coronary artery on initial admission coronary angiography or a failed PCI (final TIMI=0).
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 |
|---|---|---|
| Remote ischemic conditioning and intracoronary ischemic conditioningRIC: Four cycles of [5 min brachial cuff inflation at 200 mmHg followed by 5 min of cuff deflation] started as soon as possible prior to PCI reperfusion. At least one full cycle (inflation + deflation) has to be completed before PCI reperfusion. ICIC: Four cycles of [1 min balloon inflation followed by 1 min balloon deflation] started as soon as possible after reopening of the culprit coronary artery (maximum within 3 minutes after reflow). The balloon will be placed carefully above the culprit lesion so as to minimize potential micro-embolization. | Device | RIC+ ICIC + |
| Patients with no remote ischemic conditioning and no intracoronary ischemic conditioningBrachial cuff is positioned during 40 minutes but not inflated. No intracoronary balloon inflation. | Device | RCI - ICIC - |
Primary outcome
Combined incidence of [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months after MI, large infarct defined as CK peak at 6 hours > 4500 UI/L]
Time frame: 6 months
9 secondary outcomes
Cardiovascular death at 6 months.
Time frame: 6 months
Worsening of heart failure
Time frame: 6 months
Time to first event [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure]
Time frame: 6 months
Major Adverse Cardiac Events (MACE)
Time frame: 6 months
Renal failure
Time frame: 6 months
Peak of creatine kinase
Time frame: 4-6 hours post-PCI
creatine kinase
Time frame: 5 days
Measure hsCRP
Time frame: 5 days
Rate of CRP
Time frame: 5 days
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
Related trials for Myocardial Infarction, Acute
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
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.
Gilles Rioufol, Pr principal investigator
Hôpital Louis Pradel 28 avenue Doyen Lépine, BP Lyon-Montchat, 69394LYON cedex 03
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning and intracoronary ischemic conditioning and Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning in people with Myocardial Infarction, Acute, run by Hospices Civils de Lyon at 4 sites in 2 countries.
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 12 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, France. 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?
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
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?
Combined incidence of [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months after MI, large infarct defined as CK peak at 6 hours > 4500 UI/L] (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2026.