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Trial record 14 of 1176 for:    adenosine

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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ClinicalTrials.gov Identifier: NCT02350439
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras

Tracking Information
First Submitted Date  ICMJE January 26, 2015
First Posted Date  ICMJE January 29, 2015
Last Update Posted Date January 10, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02350439 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
  • FFR value as determined by the software, between the 2 groups. [ Time Frame: 10 minutes ]
  • FFR during steady state hyperemia. [ Time Frame: 10 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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).
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Drug: Adenosine infusion at 200μg/Kg/min
Assessment of fractional flow reserve (FFR) under high adenosine intravenous infusion dose (200mg/kg/min)
Study Arms  ICMJE Experimental: Adenosine intravenous infusion at 200μg/Kg/min
Fractional flow reserve assessment under Adenosine intravenous infusion at 200μg/Kg/min
Intervention: Drug: Adenosine infusion at 200μg/Kg/min
Publications * Alexopoulos D, Xanthopoulou I, Tsigkas G, Koutsogiannis N, Salata P, Armylagos S, Moulias A, Davlouros P. Effect of High (200 μg/kg per Minute) Adenosine Dose Infusion on Fractional Flow Reserve Variability. J Am Heart Assoc. 2016 Nov 10;5(11). pii: e004323.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2015)
30
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2015)
20
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02350439
Other Study ID Numbers  ICMJE PATRASCARDIOLOGY 19
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dimitrios Alexopoulos, University of Patras
Study Sponsor  ICMJE University of Patras
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Patras
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP