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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001916-22-GB

Enrollment

Registered

2007-07-31

Start date

2008-05-02

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

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

Interventions

Trade Name: Adenoscan (Adenosine) Product Name: Adenoscan Pharmaceutical Form: Solution for infusion Other descriptive name: Adenoscan C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: to measure the drop in FFR with higher infusion rates (180micrograms/kg/min and 200 micrograms/kg/min) of adenosine; Secondary Objective: 1. To assess the safety of high dose adenosine as measured by the degree of alteration of heart rate, PR interval, QT interval and arterial blood pressure (SBP, MAP, DBP) in response to each dose. 2. To assess teh degree of patient tolerability of teh two higher doses of adenosine as measured by early discontinuation of drug at patient request. ;Primary end point(s): The primary endpoint point is the difference in FFR with the different doses of adenosine. We aim to recruit 60 patients in order to have an 80%-90% confidence interval to detect a change of 0.03 of FFR.	—

Measure

Time frame

Main Objective: to measure the drop in FFR with higher infusion rates (180micrograms/kg/min and 200 micrograms/kg/min) of adenosine; Secondary Objective: 1. To assess the safety of high dose adenosine as measured by the degree of alteration of heart rate, PR interval, QT interval and arterial blood pressure (SBP, MAP, DBP) in response to each dose. 2. To assess teh degree of patient tolerability of teh two higher doses of adenosine as measured by early discontinuation of drug at patient request. ;Primary end point(s): The primary endpoint point is the difference in FFR with the different doses of adenosine. We aim to recruit 60 patients in order to have an 80%-90% confidence interval to detect a change of 0.03 of FFR.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026