Clinical trial NCT01158716: Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions
Official title: Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions: a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: percutaneous coronary intervention
remote ischemic preconditioning
Lead sponsor: Cardiovascular Research Society, Greece
Sponsor class: OTHER
First posted: 2010-07-08
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases, which is a sensitive and specific marker of myocyte necrosis. Myocardial necrosis may result from downstream embolization of atheromatous material, coronary side-branch occlusion and may involve ischemia/reperfusion injury. A number of studies have demonstrated that procedure-related troponin release is associated with subsequent cardiovascular events and a worst prognosis, especially in those patients with the most marked elevation in troponin concentration.

Recently, 3 cycles of 5-minute ischemia followed by 5-minute reperfusion of the upper extremities were shown to reduce troponin release in elective PCI. However, this ischemic preconditioning (IPC) protocol requires 30 minutes and is of limited use in the context of PCI at the time of initial cardiac catheterization (ad hoc coronary intervention).

Since experimental evidence suggests that IPC is a graded than an "all-or-nothing" phenomenon, and even a short, single IPC cycle may have protective effects in the myocardium, the investigators hypothesized that patients undergoing ad hoc coronary intervention would have reduced peri-procedural troponin release if subjected to a single, remote IPC cycle, between diagnostic catheterization and coronary intervention.

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%

Primary outcomes:
measure: Delta Cardiac Troponin I (ΔcTnI)
timeFrame: 24 hours post PCI
Secondary outcomes:
measure: Chest Pain During Coronary Balloon Occlusion
timeFrame: During coronary balloon occlusion
measure: ECG Evidence of Ischemia During Coronary Balloon Occlusion
timeFrame: During coronary balloon occlusion
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Athens Euroclinic
state: Attica
Study officials:
affiliation: Athens Euroclinic
name: Demosthenes G Katritsis, MD, PhD
role: STUDY_CHAIR
References: