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).

NCT ID: NCT02350439

Last Updated: 2017-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-10-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Adenosine intravenous infusion at 200μg/Kg/min

Fractional flow reserve assessment under Adenosine intravenous infusion at 200μg/Kg/min

Group Type: EXPERIMENTAL

Adenosine infusion at 200μg/Kg/min

Intervention Type: DRUG

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

Interventions

Adenosine infusion at 200μg/Kg/min

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Patras

OTHER

Sponsor Role: lead

Responsible Party

Dimitrios Alexopoulos

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Patras University Hospital

Pátrai, , Greece

Countries

Greece

References

Alexopoulos D, Xanthopoulou I, Tsigkas G, Koutsogiannis N, Salata P, Armylagos S, Moulias A, Davlouros P. Effect of High (200 mug/kg per Minute) Adenosine Dose Infusion on Fractional Flow Reserve Variability. J Am Heart Assoc. 2016 Nov 10;5(11):e004323. doi: 10.1161/JAHA.116.004323.

Reference Type: DERIVED

PMID: 27930357 (View on PubMed)

Other Identifiers

PATRASCARDIOLOGY 19

Identifier Type: -

Identifier Source: org_study_id