Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty

Coronary Angioplasty Clinical Trial

— PREVENT-ICARUS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148147
• Other study ID #: CE 93/09
• Secondary ID: 2009-013681-92
• Status: Completed
• Phase: Phase 3
• First received: June 7, 2010
• Last updated: November 7, 2011
• Start date: November 2009
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: Azienda Ospedaliero Universitaria Maggiore della Carita
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: AIFA
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Angioplasty

Intervention

Drug:
• Adenosine
Intracoronary adenosine administration (180 ug for LCA and 120 ug for RCA)
• Placebo
Intracoronary Placebo administration

Locations

Country	Name	City	State
Italy	Giuseppe De Luca	Novara

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in troponin I (> 3 times the upper normal limit)		At 12 hours after the procedure	No
Secondary	MACE(death, MI, urgent target-vessel revascularization)		72 hours	No
Secondary	Angiographic Coronary flow, as evaluated by corrected TIMI frame count.		1 minute after the final stent implantation	No