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
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Other: Remote Ischemic Preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions: a Randomized Clinical Study

Further study details as provided by Cardiovascular Research Society, Greece:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 94
Study Start Date: July 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Remote Ischemic Preconditioning 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)
No Intervention: Control

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158716

Locations
Greece
Athens Euroclinic
Athens, Attica, Greece, 11521
Sponsors and Collaborators
Cardiovascular Research Society, Greece
Investigators
Study Chair: Demosthenes G Katritsis, MD, PhD Athens Euroclinic
  More Information

No publications provided

Responsible Party: Dr D Katritsis, Head of Department of Cardiology, Athens Euroclinic, Cardiovascular Research Society, Greece
ClinicalTrials.gov Identifier: NCT01158716     History of Changes
Other Study ID Numbers: 4.7.7.2010
Study First Received: July 7, 2010
Results First Received: March 1, 2014
Last Updated: March 1, 2014
Health Authority: Greece: Ethics Committee

Keywords provided by Cardiovascular Research Society, Greece:
percutaneous coronary intervention
remote ischemic preconditioning

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014