Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Remote Ischemic Preconditioning
Sponsored by

About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring percutaneous coronary intervention, remote ischemic preconditioning
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%
Sites / Locations
- Athens Euroclinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Remote Ischemic Preconditioning
Control
Arm Description
Outcomes
Primary Outcome Measures
Delta Cardiac Troponin I (ΔcTnI)
ΔcTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography
Secondary Outcome Measures
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)
ECG Evidence of Ischemia During Coronary Balloon Occlusion
ST-segment deviation as monitored during coronary balloon occlusion
Full Information
NCT ID
NCT01158716
First Posted
July 7, 2010
Last Updated
March 1, 2014
Sponsor
Cardiovascular Research Society, Greece
1. Study Identification
Unique Protocol Identification Number
NCT01158716
Brief Title
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
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardiovascular Research Society, Greece
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
percutaneous coronary intervention, remote ischemic preconditioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remote Ischemic Preconditioning
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Remote Ischemic Preconditioning
Intervention Description
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)
Primary Outcome Measure Information:
Title
Delta Cardiac Troponin I (ΔcTnI)
Description
ΔcTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography
Time Frame
24 hours post PCI
Secondary Outcome Measure Information:
Title
Chest Pain During Coronary Balloon Occlusion
Description
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
Title
ECG Evidence of Ischemia During Coronary Balloon Occlusion
Description
ST-segment deviation as monitored during coronary balloon occlusion
Time Frame
During coronary balloon occlusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demosthenes G Katritsis, MD, PhD
Organizational Affiliation
Athens Euroclinic
Official's Role
Study Chair
Facility Information:
Facility Name
Athens Euroclinic
City
Athens
State/Province
Attica
ZIP/Postal Code
11521
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions
We'll reach out to this number within 24 hrs