Increase of adenosine doses in fractional flow reserve

• Register: ISRCTN
• Last refreshed on: 7 December 2020
• Main ID: ISRCTN14618196
• Date of registration: 15/12/2016
• Prospective Registration: No
• Primary sponsor: Lund University
• Public title: Increase of adenosine doses in fractional flow reserve
• Scientific title: Assessment of increasing intravenous adenosine dose in fractional flow reserve: a non-randomized trial
• Date of first enrolment: 10/01/2013
• Target sample size: 85
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN14618196
• Study type: Interventional
• Study design: Prospective non-randomized trial with an open-label design (Diagnostic)
• Phase: Not Specified

Countries of recruitment

Sweden

Contacts

• Name: David Sparv

Key inclusion & exclusion criteria

Inclusion criteria:
1. Age =18 years
2. Borderline-significant coronary stenosis (indication for FFR according to ESC Guidelines)
3. Signed informed consent prior to enrollment

Exclusion criteria:
1. Allergy to adenosine or contrast media
2. Baseline mean arterial pressure <60 mmHg
3. Baseline heart rate <50 bpm
4. Pharmacologically treated asthma
5. Chronic obstructive pulmonary disease equivalent to GOLD classification III and IV
6. Confusion or inability to comprehend the study information


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary artery disease
Circulatory System
Atherosclerotic heart disease

Intervention(s)

Following coronary angiography and intracoronary administration of 200µg Nitroglycerin, a 0.014-inch pressure guide wire (Primewire Prestige®/Verrata® Pressure Guide Wire, Volcano Corporation, San Diego, CA, US) was advanced through a 6-F guide catheter into the coronary artery, calibrated and subsequently advanced distal of the lesion. The infusion of intravenous adenosine (Adenosin Life Medical 5mg/ml, Life Medical Sweden AB) was started at a weight-adjusted rate, equivalent to standard dose 140 µg/kg/min and terminated when the two minutes measurement was completed. The agent was administrated through a peripheral intravenous line. FFR was recorded for two minutes (±5 seconds) and calculated by the Volcano CORE™ integrated system with the S5I® software and Case Manager (Volcano Corporation, San Diego, CA, US). Prior to the second measurement, a recovery time was mandatory for the pressure curve to return to baseline values (minimum 5 minutes). After recovery, the second measurement was performed with similar FFR technique and an intravenous adenosine infusion of 220 µg/kg/min. FFR was considered significant if <0.80. The FFR results of standard dose were used for clinical decision of revascularization. A >0.02 drift of the FFR-wire was considered clinical relevant, and if this occurred, a new calibration was performed. Consumption of caffeine was defined as a minimum of 200 ml filter coffee consumed <6h prior to FFR. The patients' coffee intake ranged between 200-400 ml.

Primary Outcome(s)

Fractional Flow Reserve values, measured as described above after each dose

Secondary Outcome(s)

Discomfort, measured using the Visual Analogue Scale straight after FFR

Secondary ID(s)

N/A

Source(s) of Monetary Support

Lunds Universitet

Ethics review

Status:
Approval date:
Contact:

The ethics review board of Lund University, 01/12/2012, ref: Dnr 2012/216

Results

• Results available: Yes
• Date Completed: 29/01/2016