Regadenoson Combined With Symptom-Limited Exercise in Patients Undergoing Myocardial Perfusion Imaging

March 18, 2013 updated by: Hartford Hospital

The Ex-Lex Trial: A Randomized Trial Combining Regadenoson With Symptom-Limited Exercise in Patients Undergoing Myocardial Perfusion Imaging

Not infrequently, a physician is faced with uncertainty regarding the ability of a patient to perform adequate exercise in the noninvasive evaluation of known or suspected coronary artery disease (CAD) by the use of radionuclide stress myocardial perfusion imaging. In selected patients, protocols that combine exercise (either low-level or symptom-limited) with vasodilator stress agents have been found to be safe and effective in both identification of the presence and severity of CAD as well as risk stratification for adverse cardiac outcome. However, currently utilized combined stress protocols have drawbacks. Further refinement of combined stress protocols would potentially lead to more appropriate stress protocol selection for patients while enhancing laboratory efficiency. The purpose of this prospective, randomized study will be to evaluate the relative merits of combining regadenoson with symptom-limited exercise in patients clinically-referred for vasodilator-exercise stress myocardial perfusion imaging for the assessment of known or suspected CAD. It is hypothesized that combining regadenoson with symptom-limited exercise is a safe and feasible stress testing modality which is non-inferior to that which combines symptom-limited exercise with dipyridamole.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and non-pregnant, non-nursing females clinically referred for vasodilator stress myocardial perfusion imaging with the addition of exercise
  • Age >=30 years

Exclusion Criteria:

  • Extremely limited functional capacity
  • Age <30 years
  • Unable or unwilling to provide informed consent
  • Pregnant or nursing females
  • Current use of methylxanthines within 12 hours of testing
  • Current use of dipyridamole or aminophylline within 48 hours of testing
  • Uncontrolled hypertension (>200 mmHg systolic/>120 mmHg diastolic)
  • Known hypertrophic cardiomyopathy with obstruction or severe aortic stenosis
  • Decompensated congestive heart failure
  • History of sick sinus syndrome or > first degree atrioventricular block in the absence of a functioning pacemaker
  • Asthma or other bronchospastic reactive airway disease
  • History of percutaneous coronary intervention or coronary artery bypass grafting, or documented history of acute myocardial infarction or unstable angina within one week of testing
  • Patients at risk for hypotensive reaction to regadenoson

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Vasodilator-exercise stress
Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise; injection of technetium-99m labeled radiopharmaceutical at peak hyperemia or peak exercise followed by SPECT myocardial perfusion imaging
Other: Symptom-limited exercise
Dipyridamole (0.56 mg/kg) over 4 minutes followed by symptom-limited exercise with technetium-99m SPECT myocardial perfusion imaging
Other Names:
  • Persantine
  • Persantine-exercise stress test
Experimental: Exercise-vasodilator stress
Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) in patients failing to achieve a standard clinical endpoint; injection of technetium-99m labeled radiopharmaceutical 15 seconds after administration of regadenoson (or at peak exercise if regadenoson not administered) followed by SPECT myocardial perfusion imaging.
Drug: Regadenoson
Regadenoson (0.4mg/5 mL) injection during symptom-limited exercise with technetium-99m SPECT myocardial perfusion imaging
Other Names:
  • Lexiscan
  • Exercise-lexiscan stress test

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Major Adverse Events or Side Effects Graded "Severe" on Symptom Questionnaire
Time Frame: 24 hours
Number of participants with any side effect (flushing, shortness of breath, headache, chest discomfort, dizziness, nausea, or abdominal pain) requiring specific treatment or graded as "severe" by the patient; or any death, myocardial infarction, or unplanned hospitalization. Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and are therefore excluded from analysis.
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Myocardial Perfusion Image Quality
Time Frame: 0 hours
Single photon emission computed tomography myocardial perfusion acquisition and image processing was performed in accordance with American Society of Nuclear Cardiology guidelines. All images were interpreted by consensus read of three investigators blinded to stress test protocol and results. Overall perfusion and gated image quality were described as excellent (no artifacts interfering with myocardial perfusion interpretation), good, fair, or poor (artifact requiring reprocessing or repeat imaging of the patient to allow for diagnostic interpretation).
0 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hartford Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Astellas Pharma Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gary V Heller, MD, PhD, Hartford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HELL002965HI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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