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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Regadenoson

Intervention Type DRUG

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

Dobutamine

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Regadenoson

Intervention Type DRUG

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

Dobutamine

Intervention Type 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.

Interventions

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Regadenoson

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

Intervention Type DRUG

Dobutamine

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

Intervention Type DRUG

Other Intervention Names

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Lexiscan Dobutrex

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No