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Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction (CARIOCA)

Primary Purpose

Myocardial Infarction, Acute

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Remote ischemic conditioning and intracoronary ischemic conditioning
Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction, Acute focused on measuring ST-elevation myocardial infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

  • 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.

Exclusion Criteria:

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).

Sites / Locations

  • Algemeen Ziekenhuis Sint Jan
  • CHU de Charleroi
  • Universitair Ziekenhuis Antwerpen
  • Hopital Louis Pradel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

RIC+ ICIC +

RCI - ICIC -

Arm Description

Patients with remote ischemic conditioning and intracoronary ischemic conditioning

Control group with no remote ischemic conditioning and no intracoronary ischemic conditioning

Outcomes

Primary Outcome Measures

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]

Secondary Outcome Measures

Cardiovascular death at 6 months.
Worsening of heart failure
Worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months.
Time to first event [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure]
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].
Renal failure
Renal failure (+25% increase in serum creatinine at 6 months versus baseline).
Peak of creatine kinase
creatine kinase
Measure hsCRP
Rate of CRP

Full Information

First Posted
May 11, 2017
Last Updated
June 22, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03155022
Brief Title
Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction
Acronym
CARIOCA
Official Title
Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction: A Multicenter, Randomized, Controlled Clinical Trial (CARIOCA Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 12, 2018 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Acute
Keywords
ST-elevation myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
750 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIC+ ICIC +
Arm Type
Experimental
Arm Description
Patients with remote ischemic conditioning and intracoronary ischemic conditioning
Arm Title
RCI - ICIC -
Arm Type
Other
Arm Description
Control group with no remote ischemic conditioning and no intracoronary ischemic conditioning
Intervention Type
Device
Intervention Name(s)
Remote ischemic conditioning and intracoronary ischemic conditioning
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning
Intervention Description
Brachial cuff is positioned during 40 minutes but not inflated. No intracoronary balloon inflation.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Cardiovascular death at 6 months.
Time Frame
6 months
Title
Worsening of heart failure
Description
Worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months.
Time Frame
6 months
Title
Time to first event [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure]
Time Frame
6 months
Title
Major Adverse Cardiac Events (MACE)
Description
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].
Time Frame
6 months
Title
Renal failure
Description
Renal failure (+25% increase in serum creatinine at 6 months versus baseline).
Time Frame
6 months
Title
Peak of creatine kinase
Time Frame
4-6 hours post-PCI
Title
creatine kinase
Time Frame
5 days
Title
Measure hsCRP
Time Frame
5 days
Title
Rate of CRP
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Rioufol, Pr
Organizational Affiliation
Hôpital Louis Pradel 28 avenue Doyen Lépine, BP Lyon-Montchat, 69394LYON cedex 03
Official's Role
Principal Investigator
Facility Information:
Facility Name
Algemeen Ziekenhuis Sint Jan
City
Brugge
Country
Belgium
Facility Name
CHU de Charleroi
City
Charleroi
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
Country
Belgium
Facility Name
Hopital Louis Pradel
City
Bron
Country
France

12. IPD Sharing Statement

Learn more about this trial

Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction

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