Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01148147

Acronym

PREVENT-ICARUS

Enrollment

260

Registered

2010-06-22

Start date

2009-11-30

Completion date

2010-08-31

Last updated

2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Angioplasty

Keywords

Adenosine, randomized trial, periprocedural myocardial necrosis, elective coronary angioplasty

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.

Interventions

DRUGAdenosine

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

DRUGPlacebo

Intracoronary Placebo administration

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Increase in troponin I (> 3 times the upper normal limit)	At 12 hours after the procedure

Secondary

Measure	Time frame
MACE(death, MI, urgent target-vessel revascularization)	72 hours
Angiographic Coronary flow, as evaluated by corrected TIMI frame count.	1 minute after the final stent implantation

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026