IschemiaPhase 4NCT02130453
Accuracy of an Echo-Stress Protocol Using Regadenoson With Speckle Tracking
A Phase 4 study testing Regadenoson in people with Ischemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to compare regadenoson nuclear stress testing with echocardiography strain measurements (an ultrasound imaging method that measures hearts function) in detecting coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemia
- What is being tested?
- Regadenoson
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2014to 28 Jun 2024
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients who are scheduled for (perfusion) nuclear stress testing using regadenoson as stress agent.
- Indications for stress testing is either: -as part of a pre-operative evaluation prior to a planned cancer related surgery that is considered to be at least of intermediate risk (Intra-peritoneal, intra-thoracic, head and neck surgery, orthopedic or prostate surgery) OR -as an evaluation in the cardiology clinic for symptoms described in a cardiology consult as typical angina, or of significant suspicion for coronary disease or symptoms described as likely of a cardiac/coronary etiology.
- Patients with a history of LV dysfunction will be still candidates for enrollment in the study if they have documented LVEF recovery (most recent documented LVEF of 50% or higher) for at least 6 months prior to SPECT regardless of current cardiac medication regimen.
- Age 18 - 80 years.
Who cannot join
- Patients consented for the trial that on the baseline 2D study have poor acoustic echo windows (i.e. a reader is unable to see in definition 2 or more segments from the apical views) will not be eligible to continue in the trial and peak hyperemia images will not be obtained.
- Any patient with tachycardia defined as HR of 100 or higher at the day of SPECT will not be eligible for this study.
- Second- or third- degree AV block.
- Sinus node dysfunction.
- Patients with allergy to regadenoson.
- Patients with LBBB and/or artificial pacemaker.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Use of Regadenoson for a Stress Echocardiogram Protocol Using Speckle Tracking Imaging
The goal of this clinical research study is to compare regadenoson nuclear stress testing with echocardiography strain measurements (an ultrasound imaging method that measures hearts function) in detecting coronary artery disease.
Read the detailed description
If you agree to take part in this study, you will have the echocardiography strain measurement performed. This will be done while you lie on an exam table. An ultrasound technician will apply a vaseline-like gel to your chest and will take the measurements by holding a transducer (a device that resembles a microphone) against your chest, sliding it back and forth. This will take about 10 minutes.
After the resting strain measurement is done, you will have the first set of nuclear images. This will be done just like the echocardiography strain measurement. Once these images are completed, you will be given regadenoson by vein over about 10 seconds. Within 2 to 4 minutes of receiving the regadenoson, measurements will be repeated. These measurements will take about 2 minutes to complete. At about 30 minutes after regadenoson was given, you will have the final images for the nuclear portion of the testing (this is the usual timing for nuclear images after regadenoson).
You will receive the same treatment during your stress test, including the same amount of regadenoson, as you would if you did not take part in this study. Some participants may be asked to allow a repeat of the strain measurements that will include an additional dose of regadenoson if the first set of images are not good enough and additional images may be taken.
Length of Study:
Your participation on this study will be over 30 days after the tests OR after surgery, whichever occurs later. Researchers will collect information from your medical record for up to 30 days after your tests.
If you have surgery or are hospitalized in the 30 days after the tests, you will be called and asked about any problems you have been having. This call should take about 10 minutes.
This is an investigational study. Regadenoson is FDA approved and is routinely used for nuclear perfusion stress testing. The use of strain measurement during an echocardiogram to detect coronary disease is investigational.
Up to 300 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Ischemia
- Being tested
- Regadenoson
- Keywords
- Ischemia, Coronary artery disease, Nuclear stress test, Stress Echocardiogram, Echocardiography strain measurement, Ultrasound cardiac imaging, ReSTE, SPECT, Regadenoson
- Medical subject headings
- Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegadenosonDrug
0.4 mg by vein given during nuclear stress testing with echocardiography strain measurements.
| Study group | Role | What they receive |
|---|---|---|
| ReSTE Cardiac Imaging | Experimental | Echocardiography strain measurement performed taking about 10 minutes. After resting strain measurement done, first set of nuclear images performed. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving the Regadenoson, measurements repeated. These measurements will take about 2 minutes to complete. Receives: Drug: Regadenoson |
| SPECT Cardiac Imaging | Other | After resting strain measurement done, first set of nuclear images taken. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving Regadenoson, measurements repeated. These measurements take about 2 minutes to complete. At about 30 minutes after Regadenoson given, participant will have final images for the nuclear portion of the testing. Receives: Drug: Regadenoson |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Accuracy of ReSTE Imaging to SPECT Imaging in Diagnosis of Ischemia
As primary analysis, paired test of equivalence used for proportions proposed by Tango to test equivalence of the two ischemia tests among tSPECT positive patients.
Measured: 1 day
Secondary outcomes (1)
Cardiac Event Rates After ReSTE and SPECT Imaging
Cardiac events after ReSTE and SPECT imaging included myocardial infarction,heart failure, sudden cardiac death, cerebrovascular accident
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study start30 Sep 2014
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for IschemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Scientific & Medical Affairs, Inc.
- Responsible party
- Sponsor
- Investigators
- Nicolas L Palaskas, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130453
- Sponsor's protocol ID
- 2013-0881
- Other IDs
- NCI-2014-01162
- Status last verified
- Jul 2024
- First submitted
- 1 May 2014
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Regadenoson for a Stress Echocardiogram Protocol Using Speckle Tracking Imaging
- ClinicalTrials.gov ID
- NCT02130453
- Acronym / sponsor ID
- 2013-0881
- Conditions
- Ischemia
- Keywords
- Ischemia, Coronary artery disease, Nuclear stress test, Stress Echocardiogram, Echocardiography strain measurement, Ultrasound cardiac imaging, ReSTE, SPECT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Astellas Scientific & Medical Affairs, Inc.
- Study start
- 30 Sep 2014 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 5 May 2014 (estimated)
- Results
- Posted 2 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to compare regadenoson nuclear stress testing with echocardiography strain measurements (an ultrasound imaging method that measures hearts function) in detecting coronary artery disease.
Detailed description
If you agree to take part in this study, you will have the echocardiography strain measurement performed. This will be done while you lie on an exam table. An ultrasound technician will apply a vaseline-like gel to your chest and will take the measurements by holding a transducer (a device that resembles a microphone) against your chest, sliding it back and forth. This will take about 10 minutes.
After the resting strain measurement is done, you will have the first set of nuclear images. This will be done just like the echocardiography strain measurement. Once these images are completed, you will be given regadenoson by vein over about 10 seconds. Within 2 to 4 minutes of receiving the regadenoson, measurements will be repeated. These measurements will take about 2 minutes to complete. At about 30 minutes after regadenoson was given, you will have the final images for the nuclear portion of the testing (this is the usual timing for nuclear images after regadenoson).
You will receive the same treatment during your stress test, including the same amount of regadenoson, as you would if you did not take part in this study. Some participants may be asked to allow a repeat of the strain measurements that will include an additional dose of regadenoson if the first set of images are not good enough and additional images may be taken.
Length of Study:
Your participation on this study will be over 30 days after the tests OR after surgery, whichever occurs later. Researchers will collect information from your medical record for up to 30 days after your tests.
If you have surgery or are hospitalized in the 30 days after the tests, you will be called and asked about any problems you have been having. This call should take about 10 minutes.
This is an investigational study. Regadenoson is FDA approved and is routinely used for nuclear perfusion stress testing. The use of strain measurement during an echocardiogram to detect coronary disease is investigational.
Up to 300 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReSTE Cardiac Imaging | Experimental | Drug: RegadenosonEchocardiography strain measurement performed taking about 10 minutes. After resting strain measurement done, first set of nuclear images performed. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving the Regadenoson, measurements repeated. These measurements will take about 2 minutes to complete. |
| SPECT Cardiac Imaging | Other | Drug: RegadenosonAfter resting strain measurement done, first set of nuclear images taken. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving Regadenoson, measurements repeated. These measurements take about 2 minutes to complete. At about 30 minutes after Regadenoson given, participant will have final images for the nuclear portion of the testing. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer patients who are scheduled for (perfusion) nuclear stress testing using regadenoson as stress agent.
- Indications for stress testing is either: -as part of a pre-operative evaluation prior to a planned cancer related surgery that is considered to be at least of intermediate risk (Intra-peritoneal, intra-thoracic, head and neck surgery, orthopedic or prostate surgery) OR -as an evaluation in the cardiology clinic for symptoms described in a cardiology consult as typical angina, or of significant suspicion for coronary disease or symptoms described as likely of a cardiac/coronary etiology.
- Patients with a history of LV dysfunction will be still candidates for enrollment in the study if they have documented LVEF recovery (most recent documented LVEF of 50% or higher) for at least 6 months prior to SPECT regardless of current cardiac medication regimen.
- Age 18 - 80 years.
Key exclusion criteria (6 listed)
- Patients consented for the trial that on the baseline 2D study have poor acoustic echo windows (i.e. a reader is unable to see in definition 2 or more segments from the apical views) will not be eligible to continue in the trial and peak hyperemia images will not be obtained.
- Any patient with tachycardia defined as HR of 100 or higher at the day of SPECT will not be eligible for this study.
- Second- or third- degree AV block.
- Sinus node dysfunction.
- Patients with allergy to regadenoson.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regadenoson0.4 mg by vein given during nuclear stress testing with echocardiography strain measurements. | Drug | ReSTE Cardiac Imaging, SPECT Cardiac Imaging |
Primary outcome
Comparison of Accuracy of ReSTE Imaging to SPECT Imaging in Diagnosis of Ischemia
Time frame: 1 day
As primary analysis, paired test of equivalence used for proportions proposed by Tango to test equivalence of the two ischemia tests among tSPECT positive patients.
1 secondary outcome
Cardiac Event Rates After ReSTE and SPECT Imaging
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas L Palaskas, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Regadenoson in people with Ischemia, run by M.D. Anderson Cancer Center at 1 site 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 4 inclusion and 6 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 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 2 Oct 2024). 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?
Comparison of Accuracy of ReSTE Imaging to SPECT Imaging in Diagnosis of Ischemia (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2024.