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
Results First Received: March 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Intervention: Other: Remote Ischemic Preconditioning

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Remote Ischemic Preconditioning 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)
Control No text entered.

Participant Flow:   Overall Study
    Remote Ischemic Preconditioning     Control  
STARTED     48     48  
COMPLETED     47     47  
NOT COMPLETED     1     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Remote Ischemic Preconditioning 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)
Control No text entered.
Total Total of all reporting groups

Baseline Measures
    Remote Ischemic Preconditioning     Control     Total  
Number of Participants  
[units: participants]
  47     47     94  
Age  
[units: years]
Mean ± Standard Deviation
  60.8  ± 10.4     60.2  ± 10.9     60.5  ± 10.6  
Gender  
[units: participants]
     
Female     5     6     11  
Male     42     41     83  



  Outcome Measures

1.  Primary:   Delta Cardiac Troponin I (ΔcTnI)   [ Time Frame: 24 hours post PCI ]

2.  Secondary:   Chest Pain During Coronary Balloon Occlusion   [ Time Frame: During coronary balloon occlusion ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   ECG Evidence of Ischemia During Coronary Balloon Occlusion   [ Time Frame: During coronary balloon occlusion ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Theodoros Zografos
Organization: Cardiovasular RS
phone: +306956161001
e-mail: theodoroszografos@gmail.com


No publications provided


Responsible Party: Dr D Katritsis, 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