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).

NCT02350439 | Completed Phase 3

• 1 other identifier: PATRASCARDIOLOGY 19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Coronary artery disease; Fractional floe reserve

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• FFR value as determined by the software, between the 2 groups.

  10 minutes

• FFR during steady state hyperemia.

  10 minutes

Study Arms (1)

Adenosine intravenous infusion at 200μg/Kg/min

EXPERIMENTAL

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

Drug: Adenosine infusion at 200μg/Kg/min

Interventions

Adenosine infusion at 200μg/Kg/min DRUG

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

Adenosine intravenous infusion at 200μg/Kg/min

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Patras University Hospital

Pátrai, Greece

Location

Related Publications (1)

• 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.

  PMID: 27930357 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: January 29, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 10, 2017

Record last verified: 2017-01

Locations

GR (1)