NCT01532206

Brief Summary

Remote ischemic preconditioning has proven beneficial in patients undergoing percutaneous coronary intervention and coronary artery bypass surgery. Animal studies suggest remote ischemic preconditioning increases levels of interleukin 10. The investigators aim to determine whether remote ischemic preconditioning results in an increase in IL-10 levels in patients following acute myocardial infarction.

Trial Health

57
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Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

February 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 14, 2012

Completed
1 year until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2013

Enrollment Period

11 months

First QC Date

February 9, 2012

Last Update Submit

March 24, 2016

Conditions

Acute Myocardial Infarction

Keywords

Remote ischemic preconditioninginflammation

Outcome Measures

Primary Outcomes (1)

  • Interleukin 10 levels

    24 hours following RIPC

Study Arms (2)

Remote ischemic preconditioning

EXPERIMENTAL

Remote ischemic preconditioning performed with Blood pressure cuff insufflation

Other: Blood pressure cuff insufflation

Standard of care

NO INTERVENTION

Standard of care

Interventions

Blood pressure cuff insufflationOTHER

Blood pressure cuff will be inflated to a pressure of 200mmHg for 5 minutes. This will be repeated x 3, separated by 5 minutes.

Remote ischemic preconditioning

Eligibility Criteria

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

You may qualify if:

  • \- Acute myocardial infarction

You may not qualify if:

  • \- Cardiogenic shock Active ischemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Steven P Schulman, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 9, 2012

First Posted

February 14, 2012

Study Start

March 1, 2013

Primary Completion

February 1, 2014

Study Completion

May 1, 2014

Last Updated

March 25, 2016

Record last verified: 2013-03

Locations

US(1)