Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty
- Registration Number
- NCT01148147
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo Intracoronary Placebo administration Adenosine Adenosine Intracoronary adenosine administration
- Primary Outcome Measures
Name Time Method Increase in troponin I (> 3 times the upper normal limit) At 12 hours after the procedure
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Giuseppe De Luca
🇮🇹Novara, Italy