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

NCT00763035 | Terminated Early Phase 1 Results FDA Drug

• 1 other identifier: IRB00006484
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Asthma; Chronic Obstructive Pulmonary Disease (COPD); Angina

Keywords

Coronary Artery Disease; Coronary Vessels; Myocardial Ischemia; Coronary Disease; Ischemic heart disease; asthma; copd

Outcome Measures

Primary Outcomes (1)

• Duration of Procedures

  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.

  1 day

Secondary Outcomes (6)

• Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire

  1 day

• Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire (Episodes of Arrhythmias, Bradycardia, and Wheezing)

  1 day

• Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire

  1 day

• Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire (Episodes of Wheezing)

  1 day

• Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire

  1 day

Study Arms (2)

A

ACTIVE COMPARATOR

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; Drug: Dobutamine

B

ACTIVE COMPARATOR

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; Drug: Dobutamine

Interventions

Regadenoson DRUG

Each participant will receive regadenoson 0.4mg (5ml) one time bolus dose at one visit.

Also known as: Lexiscan

A; B

Dobutamine DRUG

Each participant will receive dobutamine infusion (as per protocol to achieve a target heart rate of 85% of predicted for age) at another visit.

Also known as: Dobutrex

A; B

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

WAKE FOREST UNIVERSITY Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (5)

• Leaker BR, O'Connor B, Hansel TT, Barnes PJ, Meng L, Mathur VS, Lieu HD. Safety of regadenoson, an adenosine A2A receptor agonist for myocardial perfusion imaging, in mild asthma and moderate asthma patients: a randomized, double-blind, placebo-controlled trial. J Nucl Cardiol. 2008 May-Jun;15(3):329-36. doi: 10.1016/j.nuclcard.2008.02.009. Epub 2008 Apr 14.

  PMID: 18513639 BACKGROUND

• Thomas GS, Tammelin BR, Schiffman GL, Marquez R, Rice DL, Milikien D, Mathur V. Safety of regadenoson, a selective adenosine A2A agonist, in patients with chronic obstructive pulmonary disease: A randomized, double-blind, placebo-controlled trial (RegCOPD trial). J Nucl Cardiol. 2008 May-Jun;15(3):319-28. doi: 10.1016/j.nuclcard.2008.02.013. Epub 2008 Apr 14.

  PMID: 18513638 BACKGROUND

• Iskandrian AE, Bateman TM, Belardinelli L, Blackburn B, Cerqueira MD, Hendel RC, Lieu H, Mahmarian JJ, Olmsted A, Underwood SR, Vitola J, Wang W; ADVANCE MPI Investigators. Adenosine versus regadenoson comparative evaluation in myocardial perfusion imaging: results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol. 2007 Sep-Oct;14(5):645-58. doi: 10.1016/j.nuclcard.2007.06.114.

  PMID: 17826318 BACKGROUND

• Gordi T, Frohna P, Sun HL, Wolff A, Belardinelli L, Lieu H. A population pharmacokinetic/pharmacodynamic analysis of regadenoson, an adenosine A2A-receptor agonist, in healthy male volunteers. Clin Pharmacokinet. 2006;45(12):1201-12. doi: 10.2165/00003088-200645120-00005.

  PMID: 17112296 BACKGROUND

• Hendel RC, Bateman TM, Cerqueira MD, Iskandrian AE, Leppo JA, Blackburn B, Mahmarian JJ. Initial clinical experience with regadenoson, a novel selective A2A agonist for pharmacologic stress single-photon emission computed tomography myocardial perfusion imaging. J Am Coll Cardiol. 2005 Dec 6;46(11):2069-75. doi: 10.1016/j.jacc.2005.05.097. Epub 2005 Nov 9.

  PMID: 16325044 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Asthma; Pulmonary Disease, Chronic Obstructive; Angina Pectoris; Myocardial Ischemia; Coronary Disease

Interventions

regadenoson; Dobutamine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Gregory Hundley
• Organization: Wake Forest University Health Sciences

ghundley@wakehealth.edu

+1 (336) 716-0607

Study Officials

• William G Hundley, M.D., F.A.C.C., F.A.H.A

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: September 26, 2018
• Results First Posted: September 26, 2018

Record last verified: 2018-09

Locations

US (1)