Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions

Coronary Artery Disease Clinical Trial

Official title:

Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions: a Randomized Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158716
• Other study ID #: 4.7.7.2010
• Status: Completed
• Phase: N/A
• First received: July 7, 2010
• Last updated: March 1, 2014
• Start date: July 2011
• Est. completion date: June 2012

Study information

• Verified date: March 2014
• Source: Cardiovascular Research Society, Greece
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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)

Locations

Country	Name	City	State
Greece	Athens Euroclinic	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Cardiovascular Research Society, Greece

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta Cardiac Troponin I (?cTnI)	?cTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography	24 hours post PCI	Yes
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)	During coronary balloon occlusion	Yes
Secondary	ECG Evidence of Ischemia During Coronary Balloon Occlusion	ST-segment deviation as monitored during coronary balloon occlusion	During coronary balloon occlusion	Yes