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).

Sponsor

University of Patras (Other)

Overall Status

Completed

CT.gov ID

NCT02350439

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Adenosine infusion at 200μg/Kg/min	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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 :

Jan 1, 2015

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

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 groups [10 minutes]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-80 years
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).
Written informed consent

Exclusion Criteria:

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