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Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty (PREVENT-ICARUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01148147
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : November 8, 2011
Information provided by:
Azienda Ospedaliero Universitaria Maggiore della Carita

Brief Summary:
Aim of the study is to evaluate the benefits from adjunctive intracoronary administration of adenosin in elective patients undergoing coronary angioplasty.

Condition or disease Intervention/treatment Phase
Coronary Angioplasty Drug: Adenosine Drug: Placebo Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : November 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Adenosine

Arm Intervention/treatment
Placebo Comparator: Placebo
Intracoronary Placebo administration
Drug: Placebo
Intracoronary Placebo administration

Active Comparator: Adenosine
Intracoronary adenosine administration
Drug: Adenosine
Intracoronary adenosine administration (180 ug for LCA and 120 ug for RCA)

Primary Outcome Measures :
  1. Increase in troponin I (> 3 times the upper normal limit) [ Time Frame: At 12 hours after the procedure ]

Secondary Outcome Measures :
  1. MACE(death, MI, urgent target-vessel revascularization) [ Time Frame: 72 hours ]
  2. Angiographic Coronary flow, as evaluated by corrected TIMI frame count. [ Time Frame: 1 minute after the final stent implantation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01148147

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Giuseppe De Luca
Novara, Italy, 28100
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
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Principal Investigator: Giuseppe De Luca, MD AOU Maggiore della Carità
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Giuseppe De Luca, MD, PhD, AOU Maggiore della Carita - Eastern Piedmont University Identifier: NCT01148147    
Other Study ID Numbers: CE 93/09
2009-013681-92 ( Registry Identifier: EUDRACT )
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: September 2010
Keywords provided by Azienda Ospedaliero Universitaria Maggiore della Carita:
randomized trial
periprocedural myocardial necrosis
elective coronary angioplasty
Additional relevant MeSH terms:
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Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action