Study to assess the optimum dose of intravenous adenosine in the assessment of fractional flow reserve - Pressure Wire Study

Phase 1

• Conditions: To study the effects of higher dose adenosine on intermediate coronary lesions at coronary angiography which require pressure wire study.

• Registration Number: EUCTR2007-001916-22-GB
• Lead Sponsor: Central Manchester and Manchester Children's Hospital University NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-31
• Study Completion: 2010-10-07
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Any patient listed for pressure wire study of a moderate coronary artery lesion
Any patient attending for coronary angiography +/- proceed who is found to have a moderate lesion considered to require pressure wire assessment.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any patient who is unable or unwilling to give full informed consent.
Patients with a contraindication to the administration of adenosine:
Patients with a history of allergy or previous adverse reaction to administration of adenosine
Second or third degree AV block, sick sinus syndrome (except in patients with a permanent pacemaker)
Long QT syndrome
Wolff Parkinson White Syndrome
Severe hypotension (SBP <90)
Unstable angina not successfully stabilised with medical therapy
Decompensated heart failure
Severe asthma
Patients taking dipyridamole
Patients taking theophylline / aminophylline therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified