NCT00588042

Brief Summary

Ischemic preconditioning (IP) has been shown in animal studies to increase the myocardial tolerance to subsequent ischemia. Our primary hypothesis is that remote IP reduces myocardial ischemic injury during PCI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

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

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 8, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

1.7 years

First QC Date

December 21, 2007

Last Update Submit

April 15, 2019

Conditions

Coronary Artery Ischemia

Keywords

Angioplasty, Transluminal, Percutaneous CoronaryCoronary Artery DiseaseCoronary Occlusion

Outcome Measures

Primary Outcomes (1)

  • Post PCI myonecrosis measured as a maximum troponin T ≥0.03

    16 hours post PCI

Secondary Outcomes (5)

  • Post PCI myonecrosis measured as an elevation in creatine kinase MB fraction (CK-MB> 1 X upper limit of normal)

    16 hours post procedure

  • Magnitude of ST segment elevation on an intracoronary electrocardiogram during balloon inflation

    During PCI procedure

  • Coronary perfusion measured as coronary flow reserve derived from TIMI frame counts

    During PCI

  • Blood high sensitivity C-reactive protein level

    Immediately prePCI

  • Blood endothelial progenitor cell counts (EPC)

    Immediately prePCI

Study Arms (2)

1

ACTIVE COMPARATOR

Arm ischemia will be induced using a blood pressure cuff that will be placed around the upper part of the arm, and inflated to 200 mm Hg for 3-minutes and then deflated for 3-minutes

Device: Blood pressure cuff

2

SHAM COMPARATOR

3-cycles of cuff inflation (10 mmHg)-deflation will also be performed in the control group for similar durations without inducing ischemia

Device: blood pressure cuff

Interventions

blood pressure cuffDEVICE

Arm ischemia will be induced using a blood pressure cuff that will be placed around the upper part of the arm, and inflated to 200 mm Hg for 3-minutes and then deflated for 3-minutes

Also known as: sphygmomanometer
1

Eligibility Criteria

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

You may qualify if:

  • Patients will be eligible for randomization if they meet the following criteria:
  • Age ≥ 18 years
  • Clinically indicated elective or urgent PCI

You may not qualify if:

  • Patients will be ineligible for the study if one or more of the following conditions exist:
  • Pre-PCI Troponin T ≥ 0.03
  • Systemic hypotension (systolic \<90 mmHg) or cardiogenic shock
  • Presence of an arteriovenous fistula or lymphedema of either arm
  • Currently enrolled in other active cardiovascular investigational studies
  • Severe endocrine, hepatic, renal, disorders
  • Pregnancy or lactation
  • Inability to provide consent
  • Federal Medical Center inmates
  • Inability or unwillingness to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Prasad A, Gossl M, Hoyt J, Lennon RJ, Polk L, Simari R, Holmes DR Jr, Rihal CS, Lerman A. Remote ischemic preconditioning immediately before percutaneous coronary intervention does not impact myocardial necrosis, inflammatory response, and circulating endothelial progenitor cell counts: a single center randomized sham controlled trial. Catheter Cardiovasc Interv. 2013 May;81(6):930-6. doi: 10.1002/ccd.24443. Epub 2012 Nov 8.

    PMID: 22517646RESULT

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary Occlusion

Interventions

Sphygmomanometers

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and Supplies

Study Officials

  • Abhiram Prasad, MBBS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 8, 2008

Study Start

October 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

US(1)