Coronary Artery Disease Clinical Trial
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).
Verified date | January 2017 |
Source | University of Patras |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Greece | Patras University Hospital | Patras |
Lead Sponsor | Collaborator |
---|---|
University of Patras |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference between the maximum and minimum value of Pd / Pa ratio during steady state hyperaemia between the 2 groups. | 10 minutes | No | |
Primary | Coefficient of variation of Pd / Pa ratio during steady state hyperemia between the 2 groups | 10 minutes | No | |
Secondary | FFR value as determined by the software, between the 2 groups. | 10 minutes | No | |
Secondary | FFR during steady state hyperemia. | 10 minutes | No |
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