Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions
1 other identifier
interventional
94
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Jul 2011
Shorter than P25 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2010
CompletedFirst Posted
Study publicly available on registry
July 8, 2010
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
April 9, 2014
CompletedApril 9, 2014
March 1, 2014
10 months
July 7, 2010
March 1, 2014
March 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Delta Cardiac Troponin I (ΔcTnI)
ΔcTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography
24 hours post PCI
Secondary Outcomes (2)
Chest Pain During Coronary Balloon Occlusion
During coronary balloon occlusion
ECG Evidence of Ischemia During Coronary Balloon Occlusion
During coronary balloon occlusion
Study Arms (2)
Remote Ischemic Preconditioning
ACTIVE COMPARATORControl
NO INTERVENTIONInterventions
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)
Eligibility Criteria
You may qualify if:
- Patients with a significant stenosis as documented in coronary angiography eligible for PCI
- Patients ≥ 18 of age and able to give informed consent
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Athens Euroclinic
Athens, Attica, 11521, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Theodoros Zografos
- Organization
- Cardiovasular RS
Study Officials
- STUDY CHAIR
Demosthenes G Katritsis, MD, PhD
Athens Euroclinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department of Cardiology, Athens Euroclinic
Study Record Dates
First Submitted
July 7, 2010
First Posted
July 8, 2010
Study Start
July 1, 2011
Primary Completion
May 1, 2012
Study Completion
June 1, 2012
Last Updated
April 9, 2014
Results First Posted
April 9, 2014
Record last verified: 2014-03