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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).

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
Adenosine infusion at 200μg/Kg/min
Sponsored by
University of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary artery disease, Fractional floe reserve

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Patras University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adenosine intravenous infusion at 200μg/Kg/min

Arm Description

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

Outcomes

Primary Outcome Measures

Difference between the maximum and minimum value of Pd / Pa ratio during steady state hyperaemia between the 2 groups.
Coefficient of variation of Pd / Pa ratio during steady state hyperemia between the 2 groups

Secondary Outcome Measures

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

Full Information

First Posted
January 26, 2015
Last Updated
January 8, 2017
Sponsor
University of Patras
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1. Study Identification

Unique Protocol Identification Number
NCT02350439
Brief 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).
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Patras

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, Fractional floe reserve

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adenosine intravenous infusion at 200μg/Kg/min
Arm Type
Experimental
Arm Description
Fractional flow reserve assessment under Adenosine intravenous infusion at 200μg/Kg/min
Intervention Type
Drug
Intervention Name(s)
Adenosine infusion at 200μg/Kg/min
Intervention Description
Assessment of fractional flow reserve (FFR) under high adenosine intravenous infusion dose (200mg/kg/min)
Primary Outcome Measure Information:
Title
Difference between the maximum and minimum value of Pd / Pa ratio during steady state hyperaemia between the 2 groups.
Time Frame
10 minutes
Title
Coefficient of variation of Pd / Pa ratio during steady state hyperemia between the 2 groups
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
FFR value as determined by the software, between the 2 groups.
Time Frame
10 minutes
Title
FFR during steady state hyperemia.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Patras University Hospital
City
Patras
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
27930357
Citation
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.
Results Reference
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Learn more about this trial

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).

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