Myocardial Blood Flow by PET and N-13 Ammonia During Regadenoson Stress

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01370265
First received: June 6, 2011
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

The investigators propose to measure and compare regadenoson-induced hyperemic Myocardial Blood Flow (MBF) versus adenosine-induced hyperemic MBF, using PET N-13 Ammonia in healthy subjects. The protocol will provide clinically useful data for practice.


Condition Intervention
Regadenoson Stress
Drug: Regadenoson
Drug: Adenosine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Quantification of Myocardial Blood Flow by Positron Emission Tomography and N-13 Ammonia During Regadenoson Stress

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Myocardial blood flow (MBF) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    To quantify regadenoson-induced hyperemic PET N-13 ammonia MBF and compare to adenosine-induced hyperemic PET N-13 ammonia MBF.


Estimated Enrollment: 12
Study Start Date: February 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Regadenoson
To Assess Regadenoson stress PET N-13 Ammonia MBF.
Drug: Regadenoson
regadenoson (0.4 mg/5 ml IV) will be administered intravenously over 10 seconds, followed immediately by saline flush
Other Name: Lexiscan
Active Comparator: Adenosine
To assess adenosine stress PET N-13 Ammonia MBF
Drug: Adenosine
adenosine (140 μg/kg/min) will be administered intravenously over 6 minutes
Other Name: Adenoscan

Detailed Description:

Growing clinical experience and published studies support the comparable diagnostic accuracy, safety, and better subjective tolerability of regadenoson as compared to adenosine. Furthermore, while dipyridamole and adenosine are contraindicated in patients with asthma and significant chronic obstructive pulmonary disease (COPD), pilot data suggest overall safety of regadenoson in patients with mild or moderate asthma and in patients with stable moderate COPD.

The use of the cyclotron-produced and FDA-approved PET perfusion tracer, N-13 ammonia, with regadenoson has not been published. Among the nuclear perfusion tracers, N-13 ammonia provides the best image quality, high diagnostic accuracy, and the lowest total body radiation exposure. Quantification of myocardial blood flow (MBF) in ml per min per gm is also possible with N-13 ammonia, adding clinically useful information and powerful prognostic value and is increasingly utilized in clinical practice. In studies of PET with N-13 ammonia, MBF increases up to four-fold with adenosine or dipyridamole in healthy human volunteers and normal myocardium. However, the PET acquisition protocol for N-13 ammonia with regadenoson stress and the limits of normal PET measured hyperemic blood flow after regadenoson infusion have not been published. The optimal timing of N-13 ammonia administration and of PET image acquisition as well as acquisition duration following regadenoson bolus is not known. Different physical and biological properties of PET perfusion tracers necessitate specific protocols for each tracer.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Twelve healthy male and female volunteers over the age of 30.
  • Written informed consent will be obtained from each subject.
  • Each subject will undergo a history and physical examination

Exclusion Criteria:

  • Any cardiovascular or pulmonary symptoms or exam findings
  • History of low blood pressure (< 90/50 mmHg)
  • Prior cardiac history
  • History of hypertension
  • History of hyperlipidemia
  • History of diabetes mellitus
  • History of asthma or chronic obstructive pulmonary disease
  • Weight of > 450 pounds
  • Chronic kidney disease
  • Other serious illness such as cancer
  • Current smoking
  • Medication use (with the exception of acetaminophen, aspirin, NSAIDs, and thyroid hormone replacement)
  • Illicit drug use
  • Prior allergic reaction to adenosine, regadenoson, or aminophylline
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370265

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Panithaya Chareonthaitawee M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01370265     History of Changes
Other Study ID Numbers: 10-006377
Study First Received: June 6, 2011
Last Updated: February 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Regadenoson (Lexiscan)
PET N-13 ammonia imaging
Myocardial Blood Flow (MBF)
Regadenoson Stress

Additional relevant MeSH terms:
Adenosine
Regadenoson
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013