NCT01558596

Brief Summary

The investigators have previously shown that elective vascular surgery is a high-risk operation with an anticipated risk of either death or heart attack of 15%. This study is testing whether a protocol of remote ischemic preconditioning (RIPC) applied 24 hours prior to the operation is safe, feasible and reduces the incidence of an adverse, perioperative cardiac complication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_1

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

September 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
3 months until next milestone

Results Posted

Study results publicly available

December 6, 2016

Completed
Last Updated

March 22, 2017

Status Verified

February 1, 2017

Enrollment Period

4.3 years

First QC Date

March 16, 2012

Results QC Date

October 12, 2016

Last Update Submit

February 1, 2017

Conditions

Peripheral Arterial DiseaseVascular Surgery

Outcome Measures

Primary Outcomes (1)

  • Troponin I Elevation Above the Upper Reference Limit (URL)

    Troponin I is a biomarker of myocardial necrosis that may indicate myocardial damage or injury that occurs during the perioperative period

    Within 3 days of the vascular operation

Study Arms (2)

Sham

PLACEBO COMPARATOR

Blood pressure cuff inflated to 40-50 mmHg in the upper extremity

Procedure: Control

RIPC

EXPERIMENTAL

Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.

Procedure: Preconditioning

Interventions

PreconditioningPROCEDURE

Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.

RIPC
ControlPROCEDURE

Blood pressure cuff inflated to 40-50 mmHg in the upper extremity

Sham

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing elective major vascular surgery at the Minneapolis VA Medical Center for abdominal aortic aneurysm, carotid disease or limb ischemia.
  • Age \> 18.
  • Provides informed consent.

You may not qualify if:

  • Hypertensive crisis
  • Peripheral arterial disease of the upper extremities
  • Arteriovenous (AV) fistula
  • Acute Coronary Syndrome (ACS) in the last 6 months
  • Severe valvular heart disease
  • Pregnant women
  • Unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (2)

  • Garcia S, Rector TS, Zakharova M, Herrmann RR, Adabag S, Bertog S, Sandoval Y, Santilli S, Brilakis ES, McFalls EO. Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A Prospective, Randomized, Sham-Controlled Phase II Clinical Trial. J Am Heart Assoc. 2016 Sep 29;5(10):e003916. doi: 10.1161/JAHA.116.003916.

    PMID: 27688236RESULT

  • Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.

    PMID: 36645250DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Results Point of Contact

Title
Santiago Garcia, MD
Organization
Minneapolis VA Medical Center
santiago.garcia@va.gov
6124673670

Study Officials

  • Santiago A Garcia, MD

    Minneapolis VA Health Care System, Minneapolis, MN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2012

First Posted

March 20, 2012

Study Start

September 1, 2011

Primary Completion

December 1, 2015

Study Completion

September 1, 2016

Last Updated

March 22, 2017

Results First Posted

December 6, 2016

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)