Remote Ischemic Conditioning in STEMI to Decrease Infarct... | NCT03930589

Studies
Remote Ischemic Conditioning in STEMI to Decrease Infarct Size

NCT03930589

Sponsor

University of Alberta

Status

Completed

Last Update Posted

Apr 29, 2019Actual

Enrollment

251Actual

Phase

Not Applicable

Conditions

STEMI
CAD

Interventions

Remote Ischemic conditioning
Standard of care

Countries

Not provided

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

Apr 2019

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

Nov 8, 2013Actual

Primary Completion Date

Aug 31, 2017Actual

Completion Date

Nov 26, 2018Actual

First Submitted Date

Apr 30, 2018

First Submission Date that Met QC Criteria

Apr 25, 2019

First Posted Date

Apr 29, 2019Actual

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

Apr 25, 2019

Last Update Posted Date

Apr 29, 2019Actual

Name	Class
Canadian VIGOUR Centre	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Following acute STEMI patients may have significant myocardial damage and subsequent heart failure. There is currently conflicting data regarding the benefit of remote ischemic conditioning to decrease the magnitude of infarction. Remote ischemic condition is a process where by repetitive intermittent limb ischemia is used to decrease the magnitude of myocardial damage caused by coronary artery occlusion and the subsequent reperfusion injury in STEMI patients. RemCon-STEMI is a multicenter randomized trial to test the impact of remote ischemic conditioning in acute STEMI.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

251Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of care	Placebo Comparator	no intervention will occur in the standard of care arm	Other: Standard of care
Remote Ischemic Conditioning	Active Comparator	Remote ischemic conditioning using BP cuff on left arm	Procedure: Remote Ischemic conditioning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remote Ischemic conditioning	Procedure	BP cuff inflation for 5 min and deflation for 5 mins with 4 cycles	Remote Ischemic Conditioning

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite of all cause death	all cause death, cardiogenic shock or chf through 90 days	90 days

Secondary Outcomes

Measure	Description	Time Frame
long term survival	survival	up to 1 year
myocardial infarction size	mi size using peak elevation of cardiac biomarkers	within 72 hours of hospital admission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients presenting with STEMI within 6 hours of symptom onset and:

Are expected to receive reperfusion therapy with either fibrinolysis or primary PCI.
Documented informed consent (verbal)

Exclusion Criteria:

Cardiogenic shock
History of anatomical deformity or vascular complication that limit ability to conduct remote ischemic preconditioning

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34417205	Derived	Bainey KR, Zheng Y, Coulden R, Sonnex E, Thompson R, Mei J, Bastiany A, Welsh R. Remote ischaemic conditioning in ST elevation myocardial infarction: a registry-based randomised trial. Heart. 2022 May;108(9):703-709. doi: 10.1136/heartjnl-2021-319455. Epub 2021 Aug 20.

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation