N/A
N=96
Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01158716 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Delta Cardiac Troponin I (ΔcTnI) — 0.04; 0.19 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Remote Ischemic Preconditioning (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cardiovascular Research Society, Greece
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delta Cardiac Troponin I (ΔcTnI) |
0.04; 0.19 | — |
| SECONDARY Chest Pain During Coronary Balloon Occlusion |
— | — |
| SECONDARY ECG Evidence of Ischemia During Coronary Balloon Occlusion |
— | — |
Summary
Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases. Myocardial necrosis may result from downstream embolization of atheromatous material, coronary side-branch occlusion and may involve ischemia/reperfusion injury. The investigators hypothesized that a single remote ischemic preconditioning cycle would reduce peri-procedural troponin release.
Eligibility Criteria
Inclusion Criteria
- Patients with a significant stenosis as documented in coronary angiography eligible for PCI
- Patients ≥ 18 of age and able to give informed consent
Exclusion Criteria
- Severe comorbidity (estimated life expectancy <6 months)
- Use of nicorandil or glibenclamide
- Elevated baseline cTnI before PCI
- Renal disease as documented by serum creatinine before PCI
- LVEF<35%
Data sourced from ClinicalTrials.gov (NCT01158716). 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.