CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 201 enrolled
Drug / intervention
Preconditioning +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01558596
NCT01558596Phase 2Completed

Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery

VA Office of Research and Development·interventional·Posted Mar 20, 2012·Updated Mar 22, 2017

In Brief

A Phase 2 clinical trial evaluating Preconditioning and Control for Peripheral Arterial Disease and Vascular Surgery. Completed, enrolled 201 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 20, 2012
Enrollment StartSep 1, 2011
Primary CompletionDec 1, 2015
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 14.3 years ago

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.

Controlprocedure

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