Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr D Katritsis, Cardiovascular Research Society, Greece
ClinicalTrials.gov Identifier:
NCT01158716
First received: July 7, 2010
Last updated: March 1, 2014
Last verified: March 2014

July 7, 2010
March 1, 2014
July 2011
May 2012   (final data collection date for primary outcome measure)
Delta Cardiac Troponin I (ΔcTnI) [ Time Frame: 24 hours post PCI ] [ Designated as safety issue: Yes ]
ΔcTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography
Cardiac troponin I at 24 hours post PCI [ Time Frame: 24 hours post PCI ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01158716 on ClinicalTrials.gov Archive Site
  • Chest Pain During Coronary Balloon Occlusion [ Time Frame: During coronary balloon occlusion ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: During coronary balloon occlusion ] [ Designated as safety issue: Yes ]
    ST-segment deviation as monitored during coronary balloon occlusion
Major adverse cardiac events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions
Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions: a Randomized Clinical Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Coronary Artery Disease
Other: 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)
  • Active Comparator: Remote Ischemic Preconditioning
    Intervention: Other: Remote Ischemic Preconditioning
  • No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
June 2012
May 2012   (final data collection date for primary outcome measure)

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%
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01158716
4.7.7.2010
Yes
Dr D Katritsis, Cardiovascular Research Society, Greece
Cardiovascular Research Society, Greece
Not Provided
Study Chair: Demosthenes G Katritsis, MD, PhD Athens Euroclinic
Cardiovascular Research Society, Greece
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP