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OpenTrials
Completed

NCT Number: NCT01148147

Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty

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

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Key information

Conditions

Coronary Angioplasty

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Giuseppe De Luca

Novara, 28100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Adenosine

Drug

Intracoronary adenosine administration (180 ug for LCA and 120 ug for RCA)

Placebo

Drug

Intracoronary Placebo administration

Primary outcomes

  1. Increase in troponin I (> 3 times the upper normal limit)

    Time frame: At 12 hours after the procedure

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Other

Registry information

Official study 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.

Acronym: PREVENT-ICARUS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 22, 2010
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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