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).

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350439
• Other study ID #: PATRASCARDIOLOGY 19
• Status: Completed
• Phase: Phase 3
• First received: January 26, 2015
• Last updated: January 8, 2017
• Start date: January 2015
• Est. completion date: October 2015

Study information

• Verified date: January 2017
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Adenosine infusion at 200µg/Kg/min
Assessment of fractional flow reserve (FFR) under high adenosine intravenous infusion dose (200mg/kg/min)

Locations

Country	Name	City	State
Greece	Patras University Hospital	Patras

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

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