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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).

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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

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Adenosine infusion at 200μg/Kg/min Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : January 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

Arm Intervention/treatment
Experimental: Adenosine intravenous infusion at 200μg/Kg/min
Fractional flow reserve assessment under Adenosine intravenous infusion at 200μg/Kg/min
Drug: Adenosine infusion at 200μg/Kg/min
Assessment of fractional flow reserve (FFR) under high adenosine intravenous infusion dose (200mg/kg/min)




Primary Outcome Measures :
  1. Difference between the maximum and minimum value of Pd / Pa ratio during steady state hyperaemia between the 2 groups. [ Time Frame: 10 minutes ]
  2. Coefficient of variation of Pd / Pa ratio during steady state hyperemia between the 2 groups [ Time Frame: 10 minutes ]

Secondary Outcome Measures :
  1. FFR value as determined by the software, between the 2 groups. [ Time Frame: 10 minutes ]
  2. FFR during steady state hyperemia. [ Time Frame: 10 minutes ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350439


Locations
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Greece
Patras University Hospital
Patras, Greece
Sponsors and Collaborators
University of Patras

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dimitrios Alexopoulos, Professor, University of Patras
ClinicalTrials.gov Identifier: NCT02350439     History of Changes
Other Study ID Numbers: PATRASCARDIOLOGY 19
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Keywords provided by Dimitrios Alexopoulos, University of Patras:
Coronary artery disease
Fractional floe reserve
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action