Differential Effect of High (200μg/kg/Min) Adenosine Dose on Fractional Flow Reserve in Patients Presenting Variation of FFR ≥0.05 During the Usual Dose of Adenosine Infusion (140μg/kg/Min).
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|ClinicalTrials.gov Identifier: NCT02350439|
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : January 10, 2017
Fractional flow reserve (FFR) is an established invasive method for assessing the physiological significance of coronary artery stenosis. However, in recent studies it has been observed and reported some degree of variation in the fraction of the coronary artery to the aortic pressure (Pd / Pa) during the infusion of standard adenosine dose (140mg/kg/min). The observed variation may be attributed to a failure to achieve maximal hyperemia with the normal dose. The administration of adenosine at a higher dose (200μg/kg /min) may influence coronary flow reserve (FFR) eliminating Pd / Pa variation during adenosine infusion.
This is a prospective study which will be conducted in patients after coronary angiography with at least one angiographic lesion ≥50% in coronary vessels.
Patients after written consent will undergo assessment of lesion severity with FFR under a three-minute infusion of adenosine 140mg/kg/min. In patients during steady state hyperaemia (determined by visual assessment) exhibiting variation in Pd / Pa ratio ≥ 0.05 (e.g. difference of max Pd/Pa minus min Pd/Pa) the examination will be repeated after 5 min with three-minute infusion under high dose adenosine (200mg/kg/min). The minimum ratio Pd/Pa per 3 beats will be offline analyzed. The FFR during steady hyperemia state is defined as the average of the minimum ratio Pd / Pa per three beats.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Adenosine infusion at 200μg/Kg/min||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Differential Effect of High (200μg/kg/Min) Adenosine Dose on Fractional Flow Reserve in Patients Presenting Variation of FFR ≥0.05 During the Usual Dose of Adenosine Infusion (140μg/kg/Min).|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: Adenosine intravenous infusion at 200μg/Kg/min
Fractional flow reserve assessment under Adenosine intravenous infusion at 200μg/Kg/min
Drug: Adenosine infusion at 200μg/Kg/min
Assessment of fractional flow reserve (FFR) under high adenosine intravenous infusion dose (200mg/kg/min)
- Difference between the maximum and minimum value of Pd / Pa ratio during steady state hyperaemia between the 2 groups. [ Time Frame: 10 minutes ]
- Coefficient of variation of Pd / Pa ratio during steady state hyperemia between the 2 groups [ Time Frame: 10 minutes ]
- FFR value as determined by the software, between the 2 groups. [ Time Frame: 10 minutes ]
- FFR during steady state hyperemia. [ Time Frame: 10 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350439
|Patras University Hospital|