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).

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02350439
• Date of registration: 26/01/2015
• Prospective Registration: No
• Primary sponsor: University of Patras
• Public 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).
• Scientific 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).
• Date of first enrolment: January 2015
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02350439
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Greece

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Intervention(s)

Drug: Adenosine infusion at 200µg/Kg/min

Primary Outcome(s)

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]

Secondary Outcome(s)

FFR during steady state hyperemia. [Time Frame: 10 minutes]

FFR value as determined by the software, between the 2 groups. [Time Frame: 10 minutes]

Secondary ID(s)

PATRASCARDIOLOGY 19

Source(s) of Monetary Support

Please refer to primary and secondary sponsors