Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty

Azienda Ospedaliero Universitaria Maggiore della Carita260 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

260

Conditions

Coronary Angioplasty

Interventions

AdenosineDRUG

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

PlaceboDRUG

Intracoronary Placebo administration

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Locations (1)

Giuseppe De Luca

Novara, Italy

Outcomes

Primary Outcomes

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

Time frame: At 12 hours after the procedure

Secondary Outcomes

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

Data from ClinicalTrials.gov

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