Coronary Artery DiseaseNCT02628002
Anti-gravity Treadmill Exercise in Stress Myocardial Perfusion Imaging
A study testing Antigravity treadmill (Alter-G) and Conventional treadmill/regadenoson in people with Coronary Artery Disease, run by University of Cincinnati at 1 site in United States.
Trial summary
This study will test the hypothesis that the anti-gravity treadmill can be safely used in stress nuclear myocardial perfusion imaging in patients unable to perform conventional treadmill exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Antigravity treadmill (Alter-G) and Conventional treadmill/regadenoson
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 years of age who are able to ambulate.
- Women will either have a negative pregnancy test, be post-menopausal or have prior surgical infertility
- Nuclear stress SPECT imaging test ordered as exercise SPECT or regadenoson SPECT.
- If ordered for exercise SPECT, self-admission of inability to exercise on conventional treadmill. This typically includes subjects unable to exercise due to obesity, musculoskeletal disease, peripheral vascular disease, weakness or debilitation.
- Patients that initially start conventional treadmill exercise protocol and have to stop due to exercise-limiting symptoms including musculoskeletal pain and fatigue.
- Hemodynamically stable patients as defined by mean blood pressure (BP) >75 mm Hg and heart rate (HR) 60-120 beats per minute.
Who cannot join
- Hemodynamically unstable patients as defined by resting mean BP <75 and HR <60 or >120.
- Patients with acute coronary syndrome as defined by troponin elevation (>0.05) within the past 72 hours.
- Patients at high clinical risk related to severe aortic stenosis, known exercise-induced ventricular tachycardia or fibrillation, or advanced (second-degree type II or third-degree) heart block.
- Patients with left bundle branch block or paced cardiac rhythm (in whom exercise is associated with non-ischemic perfusion abnormalities).
- Patients unable to provide consent or unable to cooperate.
- Inability to physically enter onto the anti-gravity treadmill unit.
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- Pregnant women.
- Patients with a contraindication to receive regadenoson (sinus node dysfunction, high-degree heart block, active wheezing/reactive airway disease).
- At risk patient populations (prisoners or severely mentally handicapped).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
About this study
Official title: Comparison of Anti-gravity Treadmill Exercise and Regadenoson Tc-99m Tetrofosmin Single-photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging
This study will test the hypothesis that the anti-gravity treadmill can be safely used in stress nuclear myocardial perfusion imaging in patients unable to perform conventional treadmill exercise.
This will be foundational evidence on which to consider a larger clinical trial to show that the anti-gravity treadmill improves diagnostic specificity across all cardiovascular stress testing modalities including treadmill-alone, exercise stress echocardiogram, exercise SPECT as well as having implications for cardiac PET and MRI in the future.
Read the detailed description
This randomized, single blind, controlled study will enroll up to 75 subjects presenting to the nuclear cardiology stress lab for a previously ordered SPECT study. Potential subjects will be identified by the study staff and stress lab staff prior to the stress portion of their study when the potential subject states an inability to exercise to target heart rate on the conventional treadmill prior to starting exercise. The study coordinator will then be contacted to obtain informed consent from the study subject. Subjects, after signing an informed consent document, will be enrolled and will complete the enrollment. If the subject qualifies for the study, they will then be randomized with a 2:1 ratio between the test and control arms using a preprinted randomization table.
Subjects randomized to the test arm will be instructed on the proper procedure for safely entering and exercising on the anti-gravity treadmill by the stress lab and research staff. Subjects will be provided a size-appropriate pair of neoprene shorts to be worn over their clothes. The shorts attach to the anti-gravity treadmill. These shorts will be cleaned following each patient use. Test arm subjects will exercise according to the Bruce protocol unweighted to 75% of their body weight with additional unweighting to 50% during the test if unable to reach target at 75% weight. Once these subjects have reached their target heart rate on the Bruce protocol, patients will receive the Tc-99m injection as per standard clinical protocol and maintain target heart rate for 1 minute following the injection. Patients will then be brought to walk speed for recovery.
Any subject in the test arm who is unable to reach target heart rate on the anti-gravity treadmill will be slowed to walk speed and receive regadenoson and Tc-99m injections while walking. They will be maintained at 75% unweighting while walking for these injections. Subjects unable to reach target on the anti-gravity treadmill will be included in the final data safety analysis but will be excluded from the test arm image analysis.
Subjects randomized to the control arm will proceed with the clinical standard regadenoson pharmacological stress SPECT study with adjunctive low-intensity walk on conventional treadmill during regadenoson and Tc-99m injections if tolerated. If they are unable to tolerate any treadmill exercise, they will receive regadenoson and Tc-99m injections at rest. Study patients will have stable systemic blood pressure with readings equal to or greater than 90 mmHg systolic. Other inclusion and exclusion criteria are described in detail below.
All images will be acquired by the standard clinical imaging protocol and processed by a trained nuclear medicine technologist. The imaging will then be analyzed and read by an experienced nuclear cardiologist who is blinded to whether patient is in the anti-gravity treadmill or control arm. The subsequent images and values will be confirmed by a separate and blinded experienced nuclear cardiologist. The uptake counts of isotope in the left ventricle versus the background counts will be recorded and compared between the test arm and the control arm.
- Conditions
- Coronary Artery Disease
- Being tested
- Antigravity treadmill (Alter-G), Conventional treadmill/regadenoson
- Keywords
- antigravity treadmill, bruce protocol, stress myocardial perfusion imaging, single photon emission computed tomography, cardiac catheterization, [E01.370.370.380.500], [E01.370.370.380.250], [E01.370.370.380.140]
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antigravity treadmill (Alter-G)Device
Test arm subjects will exercise according to the Bruce protocol unweighted to 75% of their body weight with additional unweighting to 50% during the test if unable to reach target at 75% weight. Once these subjects have reached their target heart rate on the Bruce protocol, patients will receive the Tc-99m injection as per standard clinical protocol and maintain target heart rate for 1 minute following the injection.
Conventional treadmill/regadenosonDevice
Subjects randomized to the control arm will proceed with the clinical standard regadenoson pharmacological stress SPECT study with adjunctive low-intensity walk on conventional treadmill during regadenoson and Tc-99m injections if tolerated. If they are unable to tolerate any treadmill exercise, they will receive regadenoson and Tc-99m injections at rest. Study patients will have stable systemic blood pressure with readings equal to or greater than 90 mmHg systolic. Other inclusion and exclusion criteria are described in detail below.
| Study group | Role | What they receive |
|---|---|---|
| Test arm | Experimental | The subjects randomized to the anti-gravity treadmill arm will be instructed on the safe use of the Alter-G treadmill by the study staff. After this instruction, subjects will be exercised on the Alter-G anti-gravity treadmill using the conventional Bruce protocol with unweighting to 75% of their body weight to reach target heart rate. If the subject is unable to reach the target heart rate, they will be further unweighted to 50% of their body weight to enable the subject to reach target heart rate on the Bruce protocol. If the subject is still unable to reach target heart rate with 50% unweighting, the patient's subsequent SPECT images will be excluded from use in the research comparison to control subject images. Receives: Device: Antigravity treadmill (Alter-G) |
| Control arm | Active comparator | The control arm subjects will undergo the conventional treadmill/regadenoson pharmacological stress SPECT. Consistent with standard practice, these patients will perform adjunctive low-intensity walk on a conventional treadmill prior to regadenoson and Tc-99m injection if tolerated. Receives: Device: Conventional treadmill/regadenoson |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Safely Reach Target Heart Rate on the Anti-Gravity Treadmill
Patients who are unable to perform conventional treadmill exercise will be exercised to target heart rate on the anti-gravity treadmill for stress nuclear myocardial perfusion imaging.
Measured: 1 year
Secondary outcomes (3)
Effect of Anti-Gravity Treadmill Exercise on Heart Rate
Heart rate associated with physiologic exercise on the anti-gravity treadmill measured in patients being evaluated with myocardial perfusion imaging.
Measured: 1 year
Effect of Anti-Gravity Treadmill Exercise on Blood Pressure
Blood pressure associated with physiologic exercise on the anti-gravity treadmill measured in patients being evaluated with myocardial perfusion imaging.
Measured: 1 year
Perfusion Imaging Quality After Anti-Gravity Treadmill Exercise
The quality of the resulting perfusion images will be compared following exercise on the conventional treadmill versus anti-gravity treadmill.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myron C. Gerson, University of Cincinnati
- Investigators
- Myron Gerson, MD, Principal investigator, University of CincinnatiPatrick Daly, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628002
- Sponsor's protocol ID
- 2014-5363
- Status last verified
- May 2017
- First submitted
- 24 Mar 2015
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anti-gravity Treadmill Exercise and Regadenoson Tc-99m Tetrofosmin Single-photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging
- ClinicalTrials.gov ID
- NCT02628002
- Acronym / sponsor ID
- 2014-5363
- Conditions
- Coronary Artery Disease
- Keywords
- antigravity treadmill, bruce protocol, stress myocardial perfusion imaging, single photon emission computed tomography, cardiac catheterization, [E01.370.370.380.500], [E01.370.370.380.250], [E01.370.370.380.140]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the hypothesis that the anti-gravity treadmill can be safely used in stress nuclear myocardial perfusion imaging in patients unable to perform conventional treadmill exercise.
This will be foundational evidence on which to consider a larger clinical trial to show that the anti-gravity treadmill improves diagnostic specificity across all cardiovascular stress testing modalities including treadmill-alone, exercise stress echocardiogram, exercise SPECT as well as having implications for cardiac PET and MRI in the future.
Detailed description
This randomized, single blind, controlled study will enroll up to 75 subjects presenting to the nuclear cardiology stress lab for a previously ordered SPECT study. Potential subjects will be identified by the study staff and stress lab staff prior to the stress portion of their study when the potential subject states an inability to exercise to target heart rate on the conventional treadmill prior to starting exercise. The study coordinator will then be contacted to obtain informed consent from the study subject. Subjects, after signing an informed consent document, will be enrolled and will complete the enrollment. If the subject qualifies for the study, they will then be randomized with a 2:1 ratio between the test and control arms using a preprinted randomization table.
Subjects randomized to the test arm will be instructed on the proper procedure for safely entering and exercising on the anti-gravity treadmill by the stress lab and research staff. Subjects will be provided a size-appropriate pair of neoprene shorts to be worn over their clothes. The shorts attach to the anti-gravity treadmill. These shorts will be cleaned following each patient use. Test arm subjects will exercise according to the Bruce protocol unweighted to 75% of their body weight with additional unweighting to 50% during the test if unable to reach target at 75% weight. Once these subjects have reached their target heart rate on the Bruce protocol, patients will receive the Tc-99m injection as per standard clinical protocol and maintain target heart rate for 1 minute following the injection. Patients will then be brought to walk speed for recovery.
Any subject in the test arm who is unable to reach target heart rate on the anti-gravity treadmill will be slowed to walk speed and receive regadenoson and Tc-99m injections while walking. They will be maintained at 75% unweighting while walking for these injections. Subjects unable to reach target on the anti-gravity treadmill will be included in the final data safety analysis but will be excluded from the test arm image analysis.
Subjects randomized to the control arm will proceed with the clinical standard regadenoson pharmacological stress SPECT study with adjunctive low-intensity walk on conventional treadmill during regadenoson and Tc-99m injections if tolerated. If they are unable to tolerate any treadmill exercise, they will receive regadenoson and Tc-99m injections at rest. Study patients will have stable systemic blood pressure with readings equal to or greater than 90 mmHg systolic. Other inclusion and exclusion criteria are described in detail below.
All images will be acquired by the standard clinical imaging protocol and processed by a trained nuclear medicine technologist. The imaging will then be analyzed and read by an experienced nuclear cardiologist who is blinded to whether patient is in the anti-gravity treadmill or control arm. The subsequent images and values will be confirmed by a separate and blinded experienced nuclear cardiologist. The uptake counts of isotope in the left ventricle versus the background counts will be recorded and compared between the test arm and the control arm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test arm | Experimental | Device: Antigravity treadmill (Alter-G)The subjects randomized to the anti-gravity treadmill arm will be instructed on the safe use of the Alter-G treadmill by the study staff. After this instruction, subjects will be exercised on the Alter-G anti-gravity treadmill using the conventional Bruce protocol with unweighting to 75% of their body weight to reach target heart rate. If the subject is unable to reach the target heart rate, they will be further unweighted to 50% of their body weight to enable the subject to reach target heart rate on the Bruce protocol. If the subject is still unable to reach target heart rate with 50% unweighting, the patient's subsequent SPECT images will be excluded from use in the research comparison to control subject images. |
| Control arm | Active comparator | Device: Conventional treadmill/regadenosonThe control arm subjects will undergo the conventional treadmill/regadenoson pharmacological stress SPECT. Consistent with standard practice, these patients will perform adjunctive low-intensity walk on a conventional treadmill prior to regadenoson and Tc-99m injection if tolerated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients >18 years of age who are able to ambulate.
- Women will either have a negative pregnancy test, be post-menopausal or have prior surgical infertility
- Nuclear stress SPECT imaging test ordered as exercise SPECT or regadenoson SPECT.
- If ordered for exercise SPECT, self-admission of inability to exercise on conventional treadmill. This typically includes subjects unable to exercise due to obesity, musculoskeletal disease, peripheral vascular disease, weakness or debilitation.
- Patients that initially start conventional treadmill exercise protocol and have to stop due to exercise-limiting symptoms including musculoskeletal pain and fatigue.
Key exclusion criteria (9 listed)
- Hemodynamically unstable patients as defined by resting mean BP <75 and HR <60 or >120.
- Patients with acute coronary syndrome as defined by troponin elevation (>0.05) within the past 72 hours.
- Patients at high clinical risk related to severe aortic stenosis, known exercise-induced ventricular tachycardia or fibrillation, or advanced (second-degree type II or third-degree) heart block.
- Patients with left bundle branch block or paced cardiac rhythm (in whom exercise is associated with non-ischemic perfusion abnormalities).
- Patients unable to provide consent or unable to cooperate.
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 |
|---|---|---|
| Antigravity treadmill (Alter-G)Test arm subjects will exercise according to the Bruce protocol unweighted to 75% of their body weight with additional unweighting to 50% during the test if unable to reach target at 75% weight. Once these subjects have reached their target heart rate on the Bruce protocol, patients will receive the Tc-99m injection as per standard clinical protocol and maintain target heart rate for 1 minute following the injection. | Device | Test arm |
| Conventional treadmill/regadenosonSubjects randomized to the control arm will proceed with the clinical standard regadenoson pharmacological stress SPECT study with adjunctive low-intensity walk on conventional treadmill during regadenoson and Tc-99m injections if tolerated. If they are unable to tolerate any treadmill exercise, they will receive regadenoson and Tc-99m injections at rest. Study patients will have stable systemic blood pressure with readings equal to or greater than 90 mmHg systolic. Other inclusion and exclusion criteria are described in detail below. | Device | Control arm |
Primary outcome
Number of Participants Who Safely Reach Target Heart Rate on the Anti-Gravity Treadmill
Time frame: 1 year
Patients who are unable to perform conventional treadmill exercise will be exercised to target heart rate on the anti-gravity treadmill for stress nuclear myocardial perfusion imaging.
3 secondary outcomes
Effect of Anti-Gravity Treadmill Exercise on Heart Rate
Time frame: 1 year
Effect of Anti-Gravity Treadmill Exercise on Blood Pressure
Time frame: 1 year
Perfusion Imaging Quality After Anti-Gravity Treadmill Exercise
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: No
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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.
Myron Gerson, MD principal investigator
University of Cincinnati
Patrick Daly, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antigravity treadmill (Alter-G) and Conventional treadmill/regadenoson in people with Coronary Artery Disease, run by University of Cincinnati 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 6 inclusion and 9 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 9 May 2017. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Who Safely Reach Target Heart Rate on the Anti-Gravity Treadmill (time frame: 1 year). 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 9 May 2017.