Coronary Artery DiseasePhase 4IDEALPETNCT01109992
Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET
A Phase 4 study testing Exercise plus Regadenoson (Lexercise) and Regadenoson (Lexiscan) in people with Coronary Artery Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This is a single-center study of subjects undergoing clinically indicated heart scans for evaluation of known or suspected heart disease. We will also include 10 healthy subjects without known heart disease. We would like to study stress testing of the heart using exercise and a medication called regadenoson. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Exercise plus Regadenoson (Lexercise) and Regadenoson (Lexiscan)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to 6 Jun 2017
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Clinically indicated N-13 ammonia PET study or ten healthy volunteers
- Known coronary artery disease (prior percutaneous coronary intervention, prior coronary artery bypass surgery or Q wave MI on ECG) or intermediate to high pretest likelihood of CAD
- Able to exercise on a treadmill
- Able and willing to provide informed consent to participate in the study
Who cannot join
- Contraindications to exercise stress testing such as, unstable angina, known severe left main coronary artery stenosis, severe heart failure, uncontrolled arrhythmias, symptomatic hypotension or severe hypertension (systolic blood pressure < 90 or > 200 mmHg, respectively), or > 1st degree atrioventricular block in the absence of a functioning pacemaker.
- Subject requires emergent cardiac medical intervention or catheterization after the clinical study.
- Documented myocardial infarction (MI) ≤ 30 days prior to enrollment.
- History of percutaneous coronary intervention (PCI) ≤ 4weeks prior to enrollment.
- History of coronary artery bypass graft (CABG) ≤ 8 weeks prior to enrollment.
- History of heart transplantation.
Show all 11Show fewer
- Allergy or intolerance to aminophylline or regadenoson
- Known severe or oxygen dependent bronchoconstrictive or bronchospastic lung disease [e.g., asthma, wheezing, chronic obstructive pulmonary disease (COPD), etc.].
- Severe LV dysfunction, with ejection fraction of < 30%
- Serious non-cardiac medical illness (e.g., disseminated malignancy, severe neurological dysfunction at time of baseline PET study) or a social situation which will preclude research study participation
- History of Seizures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Womens' Hospital
Boston, Massachusetts, 02421
About this study
Official title: Integrated Dual Exercise and Lexiscan PET: IDEAL PET
This is a single-center study of subjects undergoing clinically indicated heart scans for evaluation of known or suspected heart disease. We will also include 10 healthy subjects without known heart disease. We would like to study stress testing of the heart using exercise and a medication called regadenoson. Imaging of the heart will be performed.
Read the detailed description
Regadenoson is stress agent approved by the FDA for use with myocardial perfusion imaging with technetium-99m single photon emission computed tomography (SPECT) in patients that are unable to exercise adequately. We would like to study Regadenoson in conjunction with Exercise Rubidium-82 positron emission tomography myocardial perfusion imaging (PET MPI). Regadenoson is not approved by FDA for use with Rubidium-82 PET MPI. Also, we would like to study a novel stress protocol of Regadenoson combined with symptom limited exercise stress (not FDA approved).
The objectives of this study are to assess the tolerability and safety of combined symptom limited exercise stress test with Lexiscan (Lexercise PET) compared to Lexiscan alone (Lexiscan PET), to assess image quality of Lexercise compared to Lexiscan PET and to compare relative and absolute myocardial perfusion imaging with Lexercise compared to Lexiscan PET to identify CAD.
- Conditions
- Coronary Artery Disease
- Being tested
- Exercise plus Regadenoson (Lexercise), Regadenoson (Lexiscan)
- Keywords
- coronary artery disease, exercise, regadenoson, positron emission tomography
- Medical subject headings
- Coronary Artery Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise plus Regadenoson (Lexercise)Drug
Also called Exercise plus Lexiscan
Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography
Regadenoson (Lexiscan)Drug
Regadenoson Rubidium-82 Positron Emission Tomography
| Study group | Role | What they receive |
|---|---|---|
| Regadenoson (Lexiscan) | Active comparator | Regadenoson Rubidium-82 Positron Emission Tomography Receives: Drug: Regadenoson (Lexiscan) |
| Exercise + Regadenoson (Lexercise) | Experimental | Exercise plus Regadenoson (Lexercise) Rubidium-82 Positron Emission Tomography Receives: Drug: Exercise plus Regadenoson (Lexercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Combined Exercise and Regadenoson Stress
- Count of subjects with ischemic ECG changes is reported
- Count of subjects with systolic blood pressure decrease > 20 mm Hg is reported
- Count of subjects with abnormal serum troponin T levels is reported
- Radiation dose to the staff will be measured using personal dosimeters after the Lexiscan as well as the Lexercise PET study.
Measured: Day of the research scan during the stress test
Secondary outcomes (3)
Image Quality: Heart to Liver Ratio of Counts
Sub-diaphragmatic activity: Heart to Liver Ratio was measured on the rubidium-82 and N-13 ammonia scans. Since this measure is a ratio it has no units. Mean and Standard Deviation of Ratio is reported for each group.
This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects.
Measured: Week 1 (day of the clinical scan), and Week 2 (day of the research scan)
Changes in Left Ventricular Function With Dual Exercise and Regadenoson PET
Left ventricular ejection fraction (LVEF) at stress was measured at Stress scan 1 (regadenoson) and Stress scan 2 (regadenoson or exercise + regadenoson).
This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects.
Measured: Week 1 (day of the clinical scan), and Week 2 (day of the research scan)
Peak Stress Myocardial Blood Flow
Myocardial Blood Flow Measured at Peak Hyperemia With Regadenoson or Immediately After Exercise + Regadenoson This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects.
Measured: Week 1 (day of the clinical scan), and Week 2 (day of the research scan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startFeb 2011
- Primary completion6 Jun 2017
- Study completion6 Jun 2017
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.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharmila Dorbala, MBBS, Brigham and Women's Hospital
- Investigators
- Sharmila Dorbala, MBBS, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109992
- Sponsor's protocol ID
- BWH
- Acronym
- IDEALPET
- Status last verified
- Sep 2018
- First submitted
- 16 Apr 2010
- Last updated
- 25 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chow BJ, Ananthasubramaniam K, dekemp RA, Dalipaj MM, Beanlands RS, Ruddy TD. Comparison of treadmill exercise versus dipyridamole stress with myocardial perfusion imaging using rubidium-82 positron emission tomography. J Am Coll Cardiol. 2005 Apr 19;45(8):1227-34. doi: 10.1016/j.jacc.2005.01.016.
PubMed 15837254Di Carli MF, Hachamovitch R. New technology for noninvasive evaluation of coronary artery disease. Circulation. 2007 Mar 20;115(11):1464-80. doi: 10.1161/CIRCULATIONAHA.106.629808. No abstract available.
PubMed 17372188Klocke FJ, Baird MG, Lorell BH, Bateman TM, Messer JV, Berman DS, O'Gara PT, Carabello BA, Russell RO Jr, Cerqueira MD, St John Sutton MG, DeMaria AN, Udelson JE, Kennedy JW, Verani MS, Williams KA, Antman EM, Smith SC Jr, Alpert JS, Gregoratos G, Anderson JL, Hiratzka LF, Faxon DP, Hunt SA, Fuster V, Jacobs AK, Gibbons RJ, Russell RO; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American Society for Nuclear Cardiology. ACC/AHA/ASNC guidelines for the clinical use of cardiac radionuclide imaging--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/ASNC Committee to Revise the 1995 Guidelines for the Clinical Use of Cardiac Radionuclide Imaging). Circulation. 2003 Sep 16;108(11):1404-18. doi: 10.1161/01.CIR.0000080946.42225.4D. No abstract available.
PubMed 12975245Chow BJ, Beanlands RS, Lee A, DaSilva JN, deKemp RA, Alkahtani A, Ruddy TD. Treadmill exercise produces larger perfusion defects than dipyridamole stress N-13 ammonia positron emission tomography. J Am Coll Cardiol. 2006 Jan 17;47(2):411-6. doi: 10.1016/j.jacc.2005.09.027.
PubMed 16412870Camici PG, Crea F. Coronary microvascular dysfunction. N Engl J Med. 2007 Feb 22;356(8):830-40. doi: 10.1056/NEJMra061889. No abstract available.
PubMed 17314342El Fakhri G, Sitek A, Guerin B, Kijewski MF, Di Carli MF, Moore SC. Quantitative dynamic cardiac 82Rb PET using generalized factor and compartment analyses. J Nucl Med. 2005 Aug;46(8):1264-71.
PubMed 16085581
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Dual Exercise and Lexiscan PET: IDEAL PET
- ClinicalTrials.gov ID
- NCT01109992
- Acronym / sponsor ID
- IDEALPET / BWH
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, exercise, regadenoson, positron emission tomography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 6 Jun 2017 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Posted 25 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center study of subjects undergoing clinically indicated heart scans for evaluation of known or suspected heart disease. We will also include 10 healthy subjects without known heart disease. We would like to study stress testing of the heart using exercise and a medication called regadenoson. Imaging of the heart will be performed.
Detailed description
Regadenoson is stress agent approved by the FDA for use with myocardial perfusion imaging with technetium-99m single photon emission computed tomography (SPECT) in patients that are unable to exercise adequately. We would like to study Regadenoson in conjunction with Exercise Rubidium-82 positron emission tomography myocardial perfusion imaging (PET MPI). Regadenoson is not approved by FDA for use with Rubidium-82 PET MPI. Also, we would like to study a novel stress protocol of Regadenoson combined with symptom limited exercise stress (not FDA approved).
The objectives of this study are to assess the tolerability and safety of combined symptom limited exercise stress test with Lexiscan (Lexercise PET) compared to Lexiscan alone (Lexiscan PET), to assess image quality of Lexercise compared to Lexiscan PET and to compare relative and absolute myocardial perfusion imaging with Lexercise compared to Lexiscan PET to identify CAD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regadenoson (Lexiscan) | Active comparator | Drug: Regadenoson (Lexiscan)Regadenoson Rubidium-82 Positron Emission Tomography |
| Exercise + Regadenoson (Lexercise) | Experimental | Drug: Exercise plus Regadenoson (Lexercise)Exercise plus Regadenoson (Lexercise) Rubidium-82 Positron Emission Tomography |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Clinically indicated N-13 ammonia PET study or ten healthy volunteers
- Known coronary artery disease (prior percutaneous coronary intervention, prior coronary artery bypass surgery or Q wave MI on ECG) or intermediate to high pretest likelihood of CAD
- Able to exercise on a treadmill
- Able and willing to provide informed consent to participate in the study
Key exclusion criteria (11 listed)
- Contraindications to exercise stress testing such as, unstable angina, known severe left main coronary artery stenosis, severe heart failure, uncontrolled arrhythmias, symptomatic hypotension or severe hypertension (systolic blood pressure < 90 or > 200 mmHg, respectively), or > 1st degree atrioventricular block in the absence of a functioning pacemaker.
- Subject requires emergent cardiac medical intervention or catheterization after the clinical study.
- Documented myocardial infarction (MI) ≤ 30 days prior to enrollment.
- History of percutaneous coronary intervention (PCI) ≤ 4weeks prior to enrollment.
- History of coronary artery bypass graft (CABG) ≤ 8 weeks prior to enrollment.
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 |
|---|---|---|
| Exercise plus Regadenoson (Lexercise)Also: Exercise plus LexiscanStandard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography | Drug | Exercise + Regadenoson (Lexercise) |
| Regadenoson (Lexiscan)Regadenoson Rubidium-82 Positron Emission Tomography | Drug | Regadenoson (Lexiscan) |
Primary outcome
Safety and Tolerability of Combined Exercise and Regadenoson Stress
Time frame: Day of the research scan during the stress test
1. Count of subjects with ischemic ECG changes is reported 2. Count of subjects with systolic blood pressure decrease > 20 mm Hg is reported 3. Count of subjects with abnormal serum troponin T levels is reported 4. Radiation dose to the staff will be measured using personal dosimeters after the Lexiscan as well as the Lexercise PET study.
3 secondary outcomes
Image Quality: Heart to Liver Ratio of Counts
Time frame: Week 1 (day of the clinical scan), and Week 2 (day of the research scan)
Changes in Left Ventricular Function With Dual Exercise and Regadenoson PET
Time frame: Week 1 (day of the clinical scan), and Week 2 (day of the research scan)
Peak Stress Myocardial Blood Flow
Time frame: Week 1 (day of the clinical scan), and Week 2 (day of the research scan)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15837254Chow BJ, Ananthasubramaniam K, dekemp RA, Dalipaj MM, Beanlands RS, Ruddy TD. Comparison of treadmill exercise versus dipyridamole stress with myocardial perfusion imaging using rubidium-82 positron emission tomography. J Am Coll Cardiol. 2005 Apr 19;45(8):1227-34. doi: 10.1016/j.jacc.2005.01.016.
- Background: PubMed 17372188Di Carli MF, Hachamovitch R. New technology for noninvasive evaluation of coronary artery disease. Circulation. 2007 Mar 20;115(11):1464-80. doi: 10.1161/CIRCULATIONAHA.106.629808. No abstract available.
- Background: PubMed 12975245Klocke FJ, Baird MG, Lorell BH, Bateman TM, Messer JV, Berman DS, O'Gara PT, Carabello BA, Russell RO Jr, Cerqueira MD, St John Sutton MG, DeMaria AN, Udelson JE, Kennedy JW, Verani MS, Williams KA, Antman EM, Smith SC Jr, Alpert JS, Gregoratos G, Anderson JL, Hiratzka LF, Faxon DP, Hunt SA, Fuster V, Jacobs AK, Gibbons RJ, Russell RO; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American Society for Nuclear Cardiology. ACC/AHA/ASNC guidelines for the clinical use of cardiac radionuclide imaging--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/ASNC Committee to Revise the 1995 Guidelines for the Clinical Use of Cardiac Radionuclide Imaging). Circulation. 2003 Sep 16;108(11):1404-18. doi: 10.1161/01.CIR.0000080946.42225.4D. No abstract available.
- Background: PubMed 16412870Chow BJ, Beanlands RS, Lee A, DaSilva JN, deKemp RA, Alkahtani A, Ruddy TD. Treadmill exercise produces larger perfusion defects than dipyridamole stress N-13 ammonia positron emission tomography. J Am Coll Cardiol. 2006 Jan 17;47(2):411-6. doi: 10.1016/j.jacc.2005.09.027.
- Background: PubMed 17314342Camici PG, Crea F. Coronary microvascular dysfunction. N Engl J Med. 2007 Feb 22;356(8):830-40. doi: 10.1056/NEJMra061889. No abstract available.
- Background: PubMed 16085581El Fakhri G, Sitek A, Guerin B, Kijewski MF, Di Carli MF, Moore SC. Quantitative dynamic cardiac 82Rb PET using generalized factor and compartment analyses. J Nucl Med. 2005 Aug;46(8):1264-71.
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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.
Sharmila Dorbala, MBBS principal investigator
Brigham and Women's Hospital
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 Exercise plus Regadenoson (Lexercise) and Regadenoson (Lexiscan) in people with Coronary Artery Disease, run by Brigham and Women's Hospital 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 5 inclusion and 11 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 25 Oct 2018. 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 25 Oct 2018). 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?
Safety and Tolerability of Combined Exercise and Regadenoson Stress (time frame: Day of the research scan during the stress test). 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 NCT01109992, which also lists 6 linked publications.
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 25 Oct 2018.