Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty (PREVENT-ICARUS)
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ClinicalTrials.gov Identifier: NCT01148147 |
Recruitment Status :
Completed
First Posted : June 22, 2010
Last Update Posted : November 8, 2011
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Sponsor:
Azienda Ospedaliero Universitaria Maggiore della Carita
Information provided by:
Azienda Ospedaliero Universitaria Maggiore della Carita
Tracking Information | ||||
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First Submitted Date ICMJE | June 7, 2010 | |||
First Posted Date ICMJE | June 22, 2010 | |||
Last Update Posted Date | November 8, 2011 | |||
Study Start Date ICMJE | November 2009 | |||
Actual Primary Completion Date | August 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Increase in troponin I (> 3 times the upper normal limit) [ Time Frame: At 12 hours after the procedure ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty | |||
Official Title ICMJE | Prevention of Cardiac and Vascular Periprocedural Complications in Patients Undergoing Coronary Angiography or Angioplasty: Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty. A Prospective Double-blind Randomized Trial. | |||
Brief Summary | Aim of the study is to evaluate the benefits from adjunctive intracoronary administration of adenosin in elective patients undergoing coronary angioplasty. | |||
Detailed Description | This study will investigate the effects of adjunctive intracoronary administration of adenosine on periprocedural myocardial infarction as compared to placebo. This is a double-blind randomized trial single-center study. The enrollment will last 10 months. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Coronary Angioplasty | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | De Luca G, Iorio S, Venegoni L, Marino P. Evaluation of intracoronary adenosine to prevent periprocedural myonecrosis in elective percutaneous coronary intervention (from the PREVENT-ICARUS Trial). Am J Cardiol. 2012 Jan 15;109(2):202-7. doi: 10.1016/j.amjcard.2011.08.027. Epub 2011 Oct 14. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
260 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | August 2010 | |||
Actual Primary Completion Date | August 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Marked Bradycardia (< 40 bpm)
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Italy | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01148147 | |||
Other Study ID Numbers ICMJE | CE 93/09 2009-013681-92 ( Registry Identifier: EUDRACT ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Giuseppe De Luca, MD, PhD, AOU Maggiore della Carita - Eastern Piedmont University | |||
Study Sponsor ICMJE | Azienda Ospedaliero Universitaria Maggiore della Carita | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Azienda Ospedaliero Universitaria Maggiore della Carita | |||
Verification Date | September 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |