NCT01390142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

October 18, 2013

Status Verified

October 1, 2013

Enrollment Period

1.7 years

First QC Date

July 6, 2011

Last Update Submit

October 17, 2013

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Microvascular obstruction

    5 days

  • Left ventricular remodeling

    3 months

Study Arms (3)

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

ControlPROCEDURE

Deflated blood pressure cuff placed on upper arm for 30min

Control
RIPerPROCEDURE

Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated as soon as possible after patient admission in the cathlab and repeated 3 times in total.

RIPer
RIPer + IPostPROCEDURE

Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated as soon as possible after patient admission in the cathlab and repeated 3 times in total. Within the first minute of re-established coronary flow by primo-stenting, the same balloon is re-inflated for 1 min and then deflated for 1min. This procedure of balloon inflation/deflation is repeated 4 times in total.

RIPer + IPost

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Angers - Service de Cardiologie

Angers, 49933, France

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Fabrice Prunier, MD, PhD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2011

First Posted

July 8, 2011

Study Start

July 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

October 18, 2013

Record last verified: 2013-10

Locations

FR(1)