Remote Ischemic Preconditioning Combined to Local Ischemi... | NCT01390142

Studies
Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction

NCT01390142

Sponsor

University Hospital, Angers

Status

Completed

Last Update Posted

Oct 18, 2013Estimated

Enrollment

60Actual

Phase

Phase 3

Conditions

Myocardial Infarction

Interventions

Control
RIPer
RIPer + IPost

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Jul 6, 2011

First Submission Date that Met QC Criteria

Jul 6, 2011

First Posted Date

Jul 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2013

Last Update Posted Date

Oct 18, 2013Estimated

Name	Class
Fédération Française de Cardiologie	OTHER
Société Française de Cardiologie	OTHER

Description Module

Brief Summary

RIRE-1 is a randomized, open-label with blinded end-point study that will test the hypothesis that remote ischemic preconditioning initiated at the time of the admission in the cathlab reduces infarct size in ST-segment elevation myocardial infarction (STEMI) patients treated with percutaneous coronary intervention (PCI). Furthermore, it will determine whether a combined approach remote ischemic preconditioning and local ischemic postconditioning can further reduce infarct size. Infarct size will be determined by cardiac magnetic resonance imaging at 3-month follow-up and with 72 hours area under curve of CK-MB.

Detailed Description

In the management of STEMI, prompt reperfusion of the jeopardized myocardium is the most effective way to limit infarct size, which is a major determinant of morbidity and mortality. However, restoration of blood flow may paradoxically have deleterious consequences and lead to lethal myocardial ischemia-reperfusion injury. Local ischemic postconditioning (IPost) and remote ischemic preconditioning (RIPer) are promising methods to decrease ischemia-reperfusion injury.

The hypothesis tested in this research proposal is that RIPer initiated at the time of the admission in the cathlab reduces infarct size in STEMI patients treated with PCI. Furthermore, the investigators will determine whether a combined approach RIPer + IPost can further reduce infarct size.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Experimental		Procedure: Control
RIPer	Active Comparator	Remote ischemic preconditioning	Procedure: RIPer
RIPer + IPost	Active Comparator	Remote ischemic preconditioning and Local ischemic postconditioning	Procedure: RIPer + IPost

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Control	Procedure	Deflated blood pressure cuff placed on upper arm for 30min	Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infarct size	Infarct size as assessed by 72 hours area under curve serum CK-MB and cardiac magnetic resonance imaging at 3-month follow-up	3 months

Secondary Outcomes

Measure	Description	Time Frame
Microvascular obstruction	Microvascular obstruction as assessed by cardiac magnetic resonance imaging at 5-day follow-up	5 days
Left ventricular remodeling	Left ventricular remodeling as assessed by cardiac magnetic resonance imaging at 5-day and 3-month follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18
ST-Segment elevation myocardial infarction <6h
Written informed consent

Exclusion Criteria:

Previous Q-wave myocardial infarction or previous coronary artery bypass graft
Cardiogenic shock
Cardiac arrest resuscitated before angioplasty
Infarct related artery : circumflex coronary artery, right coronary artery after segment 3, left main, diagonal and marginal branches, and all coronary artery with jeopardized myocardium estimated too small.
TIMI 2 or 3 before angioplasty
Collateral branches Rentrop >1
TIMI 0 or 1 flow grade after PCI
Any contraindications to magnetic resonance imaging
Allergy to gadolinium
Patient refusal / patient not having provided written informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fabrice Prunier, MD, PhD	University Hospital, Angers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Angers - Service de Cardiologie		Angers		49933	France

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided