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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).

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).

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02350439
Enrollment
30
Registered
2015-01-29
Start date
2015-01-31
Completion date
2015-10-31
Last updated
2017-01-10

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

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease, Fractional floe reserve

Brief summary

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.

Interventions

DRUGAdenosine infusion at 200μg/Kg/min

Assessment of fractional flow reserve (FFR) under high adenosine intravenous infusion dose (200mg/kg/min)

Sponsors

University of Patras
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Age 18-80 years 2. Patients with at least 1 ≥50% stenosis in a coronary vessel, subjected to FFR assessment, who exhibit variation in Pd / Pa ratio ≥ 0.05 (e.g. difference of max Pd/Pa minus min Pd/Pa) during steady state hyperaemia (determined by visual assessment). 3. Written informed consent

Exclusion criteria

1. Left main disease (angiographically\> 50%) 2. Cardiogenic shock / hemodynamic instability 3. Previous CABG 4. Increased risk of bradycardia on investigator clinical judgment 5. Severe chronic obstructive pulmonary disease 6. Coronary vessels with tortuosity or extremely calcified 7. Severe left ventricular hypertrophy or severe valvular disease 8. STEMI or non-STEMI within the past five days 9. Previous myocardial infarction in the distribution of the target vessel for the FFR 10. Acute decompensated heart failure.

Design outcomes

Primary

MeasureTime frame
Difference between the maximum and minimum value of Pd / Pa ratio during steady state hyperaemia between the 2 groups.10 minutes
Coefficient of variation of Pd / Pa ratio during steady state hyperemia between the 2 groups10 minutes

Secondary

MeasureTime frame
FFR value as determined by the software, between the 2 groups.10 minutes
FFR during steady state hyperemia.10 minutes

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026