N/A
Completed N=55
Protection of the Heart With Remote Ischemic Preconditioning During Heart Surgery: A Pilot Study
Remote Ischemic Preconditioning · Myocardial Protection
Source: ClinicalTrials.gov NCT00546390 ↗
Enrolled (actual)
55
Serious AEs
10.9%
Results posted
Feb 2019
Primary outcomePrimary: Myocardial Protection Against Ischemic Injury — 298; 231 pg/ml
Summary
The purpose of this study is to compare a treatment called remote ischemic preconditioning (rIP) to no treatment. rIP is a simple treatment that is believed to help patients recover better after heart surgery. This treatment involves applying a large blood pressure cuff to one leg. The blood pressure cuffs will be inflated for 5 minutes and then deflated for 5 minutes. This will be done 4 times in a row.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Myocardial Protection Against Ischemic Injury |
298; 231 | — |
| SECONDARY All-cause Death and Cardiovascular Long-term Outcome |
0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent
- Age 18 through 80 years, inclusive
- Scheduled for heart surgery with CPB
Exclusion Criteria
- Females of childbearing potential
- Emergency surgery
- Previous sternotomy
- Myocardial infarction within 48 hours prior to surgery
- Diabetes and/or BMI >35
- Need for Alpha2-agonists perioperatively
- Peripheral Vascular Disease
Data sourced from ClinicalTrials.gov (NCT00546390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.