This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Intervention: Other: Remote Ischemic Preconditioning

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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.
No text entered.

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 
Overall Participants Analyzed 
[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.  

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.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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



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