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Comparison of Dobutamine and Regadenoson Stress Cardiac Magnetic Resonance (MR)

This study has been terminated.
(Potential participants with COPD/asthma unwilling to participate.)
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT00763035
First received: September 26, 2008
Last updated: July 28, 2011
Last verified: April 2010
  Purpose

The goal of this research is to determine the utility of Regadenoson (Lexiscan)for use as an imaging agent with cardiac MR. If found useful, it will help us establish a protocol for regadenoson stress MR perfusion (Regadenoson stress test with cardiac MR).The investigators will compare regadenoson with dobutamine so each participant will undergo two studies. A cardiac MR stress test with regadenoson and with dobutamine. The investigators participants will include patients with history of COPD and Asthma, so it will also help us determine feasibility of Regadenoson in these patient's subgroups.


Condition Intervention Phase
Coronary Artery Disease
Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Angina
Drug: Regadenoson, Dobutamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Dobutamine and Regadenoson Stress CMR

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • Duration of procedures [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    To compare the time involved during pharmacologic stress testing using regadenoson versus intravenous dobutamine in individuals with moderate to severe chronic obstructive pulmonary disease (COPD)or asthma.


Secondary Outcome Measures:
  • Ease of Administration of regadenoson versus intravenous dobutamine. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacologic stress testin in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma.


Estimated Enrollment: 40
Study Start Date: January 2009
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Arm A will get Dobutamine Stress test with cardiac MR (CMR). Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing.
Drug: Regadenoson, Dobutamine
Cross-over design in which each participant will receive regadenoson 0.4mg (5ml) one time bolus dose at one visit and dobutamine infusion (as per protocol to achieve a target heart rate of 85% of predicted for age) at another visit.
Other Name: Lexiscan
Active Comparator: B
Arm B will get Regadenoson stress test with CMR. Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing.
Drug: Regadenoson, Dobutamine
Cross-over design in which each participant will receive regadenoson 0.4mg (5ml) one time bolus dose at one visit and dobutamine infusion (as per protocol to achieve a target heart rate of 85% of predicted for age) at another visit.
Other Name: Lexiscan

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged 40 to 85 years with OBSTRUCTIVE AIRWAY DISEASES (ASTHMA AND COPD) and a forced expiratory volume (FEV1) > 0.5.
  • Patients should have a clinical indication to undergo cardiac stress test with dobutamine.

Exclusion Criteria:

  • Those with pacemakers, defibrillators, functioning neural stimulator devices or other implanted electronic devices.
  • Ferromagnetic cerebral aneurism clips or other intraorbital and intracranial metal.
  • An allergy to Gadolinium or other severe drug allergies.
  • Acute myocardial infarction within 3 months.
  • Moderate or severe aortic stenosis or other significant valvular disease;
  • Claustrophobia.
  • High grade (2o or 3o) AV Block.
  • Closed angle glaucoma.
  • Participants unable to provide informed consent.
  • Renal dialysis (subjects with moderate-to-severe renal impairment defined as eGFR < 60 mL/min.
  • A contraindication to receipt of dobutamine.
  • Participants with known coronary artery disease will be included with the exception that patients with left main or narrowings >50% in the distributions of the left anterior descending, circumflex, and right coronary artery will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763035

Locations
United States, North Carolina
WAKE FOREST UNIVERSITY Baptist Medical Center
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest Baptist Health
Astellas Pharma US, Inc.
Investigators
Principal Investigator: William G Hundley, M.D., F.A.C.C., F.A.H.A Wake Forest School of Medicine
  More Information

Publications:

Responsible Party: WILLIAM GREGORY HUNDLEY MD, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT00763035     History of Changes
Other Study ID Numbers: Hundley-2
Study First Received: September 26, 2008
Last Updated: July 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Wake Forest Baptist Health:
Coronary Artery Disease
Coronary Vessels
Myocardial Ischemia
Coronary Disease
Ischemic heart disease
asthma
copd

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Lung Diseases
Lung Diseases, Obstructive
Myocardial Ischemia
Pulmonary Disease, Chronic Obstructive
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Respiratory Tract Diseases
Vascular Diseases
Dobutamine
Regadenoson
Adenosine A2 Receptor Agonists
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Purinergic Agents
Purinergic Agonists

ClinicalTrials.gov processed this record on November 20, 2014