NCT02164695

Brief Summary

To evaluate whether remote ischemic per-conditioning (RIPC) can reduce infarct size in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention (PPCI) within 12 hours of symptoms onset.

  • Control group: PPCI only
  • Study group: PPCI + RIPC Primary endpoint: Infarct size measured by contrast-enhanced cardiac magnetic resonance (CMR) at 6 months after the index procedure

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

January 31, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

2.5 years

First QC Date

June 12, 2014

Last Update Submit

November 23, 2021

Conditions

ST-segment Elevation Myocardial Infarction

Keywords

ST-segment elevation myocardial infarctionRemote ischemic perconditioningPrimary percutaneous coronary interventionCardiac magnetic resonance

Outcome Measures

Primary Outcomes (1)

  • Infarct size measured by contrast-enhanced cardiac magnetic resonance

    Infarct size will be assessed on late-contrast images (≈10 min after gadolinium administration) by manually tracing the hyperintense area in each short-axis slice.

    6 months after index procedure

Secondary Outcomes (3)

  • Enzymatic Infarct Size

    1 to 5 days after index procedure

  • Resolution of ST-segment deviation

    1 to 5 days after index procedure

  • Acute kidney injury

    1 to 3 days after index procedure

Study Arms (2)

PPCI plus RIPC

ACTIVE COMPARATOR

The patients randomized to PPCI plus RIPC group will receive RIPC during PPCI.

Procedure: PPCI plus RIPC

PPCI only

SHAM COMPARATOR

The patients randomized to PPCI only group will receive PPCI only but the sham procedure of RIPC.

Procedure: PPCI only

Interventions

PPCI plus RIPCPROCEDURE

All patients will be prepared with an upper-arm blood pressure cuff before arterial puncture (contralateral in case of radial access). In patients allocated into PPCI plus RIPC group, the protocol will be started immediately after cuff preparation. Upper-arm will be exposed to 4 cycles of ischemia/reperfusion, each obtained by 5 min cuff inflation at 200mmHg, followed by 5 min complete deflation.

PPCI plus RIPC
PPCI onlyPROCEDURE

All patients randomized to PPCI only arm, the blood pressure cuff will be applied to the arm or the calf but will not be inflated.

PPCI only

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>19 years
  • Presenting within 12 hours of symptom onset
  • \>20 min of chest pain
  • ST-elevation myocardial infarction defined as ST-segment elevation (\>0.1 mV) in at least 2 contiguous precordial leads

You may not qualify if:

  • Previous myocardial infarction
  • Presence of chronic total occlusion
  • Evidence of retrograde filling by collaterals at coronary angiography (Rentrop 2 or 3 collateral flow)
  • Severe multi-vessel coronary artery disease to require further interventions before follow-up CMR
  • Cardiac arrest before randomization
  • Arrhythmias requiring external electric shock before randomization
  • Unwillingness to participate
  • External electric shock for cardioversion within first 3 days
  • Cardiac surgery within first 3 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 220060, South Korea

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Young Jin Youn, MD

    Yonsei Univeristy Wonju College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
CMR results will be interpreted by observers blinded to randomization
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: * Control group: PPCI only * Study group: PPCI + RIPC
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Division of Cardiology, Department of Internal Medicine, Yonsei Univeristy Wonju College of Medicine

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 16, 2014

Study Start

January 31, 2015

Primary Completion

July 31, 2017

Study Completion

January 31, 2018

Last Updated

November 24, 2021

Record last verified: 2021-11

Locations

KR(1)