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Trial record 22 of 1136 for:    adenosine

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
Sponsor:
Information provided by:
Azienda Ospedaliero Universitaria Maggiore della Carita

Tracking Information
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
 (submitted: June 21, 2010)
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 Complete list of historical versions of study NCT01148147 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2010)
  • MACE(death, MI, urgent target-vessel revascularization) [ Time Frame: 72 hours ]
  • Angiographic Coronary flow, as evaluated by corrected TIMI frame count. [ Time Frame: 1 minute after the final stent implantation ]
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.

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
Condition  ICMJE Coronary Angioplasty
Intervention  ICMJE
  • Drug: Adenosine
    Intracoronary adenosine administration (180 ug for LCA and 120 ug for RCA)
  • Drug: Placebo
    Intracoronary Placebo administration
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intracoronary Placebo administration
    Intervention: Drug: Placebo
  • Active Comparator: Adenosine
    Intracoronary adenosine administration
    Intervention: Drug: Adenosine
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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 21, 2010)
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:

  • Patients undergoing elective coronary angioplasty

Exclusion Criteria:

Marked Bradycardia (< 40 bpm)

  • Previous allergy to adenosine
  • Inability to sign the informed consent
  • Asthma
  • Elevated cardiac enzymes (troponin I o CK-MB)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 )
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
Principal Investigator: Giuseppe De Luca, MD AOU Maggiore della Carità
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