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NCT Number: NCT02350439

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).

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Patras University Hospital

Pátrai, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adenosine infusion at 200μg/Kg/min

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 29, 2015
Registry last updated
Jan 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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