Coronary Artery Disease
Conditions
Keywords
percutaneous coronary intervention, remote ischemic preconditioning
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.
Interventions
OTHERRemote Ischemic Preconditioning
Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
Sponsors
Cardiovascular Research Society, Greece
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delta Cardiac Troponin I (ΔcTnI) | 24 hours post PCI | ΔcTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chest Pain During Coronary Balloon Occlusion | During coronary balloon occlusion | Chest pain severity was assessed with a 10 point scale (0: no pain, 10: most severe discomfort ever experienced) |
| ECG Evidence of Ischemia During Coronary Balloon Occlusion | During coronary balloon occlusion | ST-segment deviation as monitored during coronary balloon occlusion |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Remote Ischemic Preconditioning Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg) | 47 |
| Control | 47 |
| Total | 94 |
Baseline characteristics
| Characteristic | Remote Ischemic Preconditioning | Control | Total |
|---|---|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 10.4 | 60.2 years STANDARD_DEVIATION 10.9 | 60.5 years STANDARD_DEVIATION 10.6 |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 42 Participants | 41 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 47 | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 |
Outcome results
Primary
Delta Cardiac Troponin I (ΔcTnI)
ΔcTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography
Time frame: 24 hours post PCI
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remote Ischemic Preconditioning | Delta Cardiac Troponin I (ΔcTnI) | 0.04 ng/mL |
| Control | Delta Cardiac Troponin I (ΔcTnI) | 0.19 ng/mL |
Secondary
Chest Pain During Coronary Balloon Occlusion
Chest pain severity was assessed with a 10 point scale (0: no pain, 10: most severe discomfort ever experienced)
Time frame: During coronary balloon occlusion
Secondary
ECG Evidence of Ischemia During Coronary Balloon Occlusion
ST-segment deviation as monitored during coronary balloon occlusion
Time frame: During coronary balloon occlusion