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Coronary Artery Disease (CAD)Phase 2NCT01334918

A Study of Regadenoson in Subjects Undergoing Stress Myocardial Perfusion Imaging (MPI) Using Multidetector Computed Tomography (MDCT) Compared to Single Photon Emission Computed Tomography (SPECT)

A Phase 2 study testing regadenoson, technetium Tc99m sestamibi /technetium Tc99m tetrafosmin and Contrast in people with Coronary Artery Disease (CAD), run by Astellas Pharma Inc at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare Multidetector Computed Tomography (MDCT) and Single Photon Emission Computed Tomography (SPECT) stress myocardial perfusion imaging (MPI) with regadenoson in order to detect the presence or absence of reversible defects. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Coronary Artery Disease (CAD)
What is being tested?
regadenoson, technetium Tc99m sestamibi /technetium Tc99m tetrafosmin and Contrast
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
11 sitesUnited States
Study dates
26 Apr 2011to 2 Jul 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male subjects must be ≥ 45 years of age
  • Female subjects must be ≥ 50 years of age
  • Subject has met at least one of the following three criteria:
  • has a suspected (clinical impression) or known diagnosis of coronary artery disease (CAD) with typical angina that has been referred from nuclear cardiology lab schedule or cardiac computed tomography (CT) schedule
  • has stable symptoms with possible elective catheterization procedure scheduled and where further imaging may be beneficial;
  • has known CAD from a previous invasive coronary angiography (ICA) performed more than 12 weeks prior to screening who now present with new cardiac symptoms
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  • Subject has been referred for a clinically indicated myocardial perfusion imaging procedure or Cardiac CT procedure for suspected moderate or high risk CAD
  • Subject must abstain from eating and drinking 30 minutes prior and 30 minutes post study drug administration
  • Subject must abstain from smoking 3 hours prior and 8 hours post study drug administration
  • Subject must abstain from any intake of methylxanthine-containing foods and beverages within 12 hours prior to Day 1 visit through the Day 3 Follow-Up Visit, as these foods may alter regadenoson effects. Subject is able to safely abstain from theophylline use for 12 hours prior to study drug administration

Who cannot join

  • Subject is concurrently participating in another drug study or has received an investigational drug within 30 days prior to Screening
  • Subject has a history of a clinically significant illness (other than CAD), medical condition, or laboratory abnormality, which would preclude participation in the study
  • Subject has renal dysfunction demonstrated by a glomerular filtration rate (GFR) < 45 mL/min (calculated using Cockroft-Gault formula Note: Subjects with a GFR 45-60 mL/min will undergo a hydration procedure
  • Female subject who is pregnant, lactating or of childbearing potential that refuses to use a medically acceptable form of contraception until the Telephone Follow up Visit is complete
  • Female subject has a positive pregnancy test prior to randomization
  • Subject has a history of second or third degree heart block or sinus node dysfunction unless the subject has a functioning pacemaker
Show all 13Show fewer
  • Subject has symptomatic hypotension (temporary and reversible conditions that no longer exist are allowed)
  • Subject is allergic or intolerant to aminophylline, nitroglycerin or metoprolol
  • Subject is allergic or intolerant to regadenoson or any of its excipients
  • Subject is unable or unwilling to comply with the procedure schedule
  • Subject has previously enrolled in this study or was enrolled in another regadenoson study sponsored by Astellas
  • Subject has atrial fibrillation or significant arrhythmias which may result in decreased image quality for the imaging studies (CT and SPECT)
  • Subject has high heart rate (> 65 beats per minute) and contra-indications to administer beta-blockers (severe chronic obstructive pulmonary disease (COPD) or asthma, second and third degree atrioventricular block)

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Maine Research Associates

    Auburn, Maine, 04210

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Cardiovascular Research Center of South Florida

    Miami, Florida, 33173

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • Midwest Cardiology Associates, P.C.

    Overland Park, Kansas, 66029

  • Berkshire Medical Center

    Pittsfield, Massachusetts, 01201

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • Harbor UCLA Medical Center

    Torrance, California, 90502

Other trials in United States

About this study

Official title: A Phase 2, Open-Label, Randomized, Cross-Over Study of Regadenoson in Subjects Undergoing Stress Myocardial Perfusion Imaging by Multidetector Computed Tomography (MDCT) and Single Photon Emission Computed Tomography (SPECT)

The purpose of this study is to compare Multidetector Computed Tomography (MDCT) and Single Photon Emission Computed Tomography (SPECT) stress myocardial perfusion imaging (MPI) with regadenoson in order to detect the presence or absence of reversible defects.

Read the detailed description

All participants will be randomized to one of two imaging sequences: rest/stress SPECT on Day 1 followed by stress/rest MDCT on Day 2 or stress/rest MDCT on Day 1 followed by rest/stress SPECT on Day 2. All stress scans will involve the injection of regadenoson as the pharmacologic stress agent.

Being tested
regadenoson, technetium Tc99m sestamibi /technetium Tc99m tetrafosmin, Contrast, Single Photon Emission Computed Tomography, Multidetector Computed Tomography
Keywords
pharmacologic stress, Coronary Artery Disease (CAD), regadenoson, ischemia
Medical subject headings
Coronary Artery Disease, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • regadenosonDrug

    Also called CVT 3146, Lexiscan

    Administered by intravenous bolus.

  • technetium Tc99m sestamibi /technetium Tc99m tetrafosminRadiation

    Also called Cardiolite, Myoview

    Administered by intravenous infusion

  • ContrastRadiation

    Administered by intravenous infusion.

  • Single Photon Emission Computed TomographyProcedure or surgery

    Procedure/Surgery

  • Multidetector Computed TomographyProcedure or surgery

    Procedure/Surgery

Study groups in NCT01334918
Study groupRoleWhat they receive
Single Photon Emission Computed Tomography (SPECT)ExperimentalResting SPECT imaging was performed prior to regadenoson stress SPECT imaging. Imaging was conducted with one of two radiotracers (99mTc sestamibi or tetrofosmin). Regadenoson 0.4 mg was administered prior to stress SPECT as a single bolus injection.
Receives: Drug: regadenoson; Radiation: technetium Tc99m sestamibi /technetium Tc99m tetrafosmin; Radiation: Contrast; Procedure: Single Photon Emission Computed Tomography; Procedure: Multidetector Computed Tomography
Multidetector Computed Tomography (MDCT)ExperimentalMultidetector Computed Tomography (MDCT), composed of CCTA and regadenoson CTP. Regadenoson stress CTP was performed prior to rest CCTA/CTP imaging. Regadenoson 0.4 mg was administered prior to stress CTP as a single bolus injection. The rest CCTA/CTP was performed at least 30 minutes after completion of the stress CTP, after resolution of any symptoms brought on by the regadenoson infusion and after the participant's heart rate had returned to baseline.
Receives: Drug: regadenoson; Radiation: technetium Tc99m sestamibi /technetium Tc99m tetrafosmin; Radiation: Contrast; Procedure: Single Photon Emission Computed Tomography; Procedure: Multidetector Computed Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Reversible Defects

    The number of reversible defects categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed: -0: normal perfusion -1: slightly reduced contrast/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from the 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of 2 or more segments with reversible defects, excluding segment 17.

    Measured: Day 1 and Day 2

Secondary outcomes (6)

  1. Overall Image Quality of Scans by Modality and Reviewer

    Overall image quality was assessed by three independent blinded readers for each modality (single photon emission computed tomography (SPECT) and multidetector computed tomography (MDCT)). Image quality was rated on a 4-point scale as either excellent, good, fair or poor at rest using SPECT and MDCT and under stress using regadenoson SPECT and regadenoson stress computed tomography perfusion (CTP).

    Measured: Day 1 and Day 2

  2. Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD)

    The number of reversible defects in the LAD categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed: -0: normal perfusion -1: slightly reduced contrast/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17.

    Measured: Day 1 and Day 2

  3. Number of Participants With Reversible Defects in the Right Coronary Artery (RCA)

    The number of reversible defects in the RCA categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed: -0: normal perfusion -1: slightly reduced contrast/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17.

    Measured: Day 1 and Day 2

  4. Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX)

    The number of reversible defects in the LCX categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed: -0: normal perfusion -1: slightly reduced contrast/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17.

    Measured: Day 1 and Day 2

  5. Number of Participants With Fixed Defects

    Using the 17-segment scoring system, a segment scored above 1 (i.e., 2 to 4) and equal at rest and stress was counted as having a fixed defect. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed: -0: normal perfusion -1: slightly reduced contrast/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake.

    Measured: Day 1 and Day 2

  6. Percentage of Participants With Two or More Ischemic Segments on SPECT, But Less on CT

    Using SPECT as the reference standard, the false negative percentage was calculated as the percentage of participants with two or more ischemic segments on SPECT, but less on CT.

    Measured: Day 1 and Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2011 (estimated)
  2. Study start26 Apr 2011
  3. Primary completion2 Jul 2012
  4. Study completion2 Jul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01334918
Sponsor's protocol ID
3606-CL-2001
Status last verified
Nov 2024
First submitted
12 Apr 2011
Last updated
4 Dec 2024
Data monitoring committee
No
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Cury RC, Kitt TM, Feaheny K, Akin J, George RT. Regadenoson-stress myocardial CT perfusion and single-photon emission CT: rationale, design, and acquisition methods of a prospective, multicenter, multivendor comparison. J Cardiovasc Comput Tomogr. 2014 Jan-Feb;8(1):2-12. doi: 10.1016/j.jcct.2013.09.004. Epub 2013 Oct 18.

    PubMed 24314823

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing regadenoson, technetium Tc99m sestamibi /technetium Tc99m tetrafosmin and Contrast in people with Coronary Artery Disease (CAD), run by Astellas Pharma Inc at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Reversible Defects (time frame: Day 1 and Day 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01334918, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.

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