Peripheral Arterial DiseaseNCT02791204
SPECT/CT Imaging of Skeletal Muscle Perfusion
An observational study of Peripheral Arterial Disease and Diabetes Mellitus, run by Yale University at 1 site in United States.
Trial summary
This study will use SPECT/CT imaging to assess the effect of percutaneous revascularization treatments in patients with Peripheral arterial disease and diabetes mellitus, in whom the disease can progress more quickly than in patients without diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease, Diabetes Mellitus
- What is being tested?
- SPECT/CT imaging following revascularization procedures and SPECT/CT imaging
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 30 Jan 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: * healthy control subjects will be enrolled for this study. * PAD patients with diabetes who are undergoing revascularization procedures * patients undergoing clinically indicated myocardial perfusion imaging study
Who may be able to join
- At least 18 years of age
- Normal (0.9-1.2) Ankle Brachial Index
- Inclusion Criteria for patients undergoing clinically indicated myocardial perfusion study:
- 1) At least 18 years of age 2) scheduled for stress myocardial perfusion imaging study for clinically indicated reason
- -Inclusion Criteria for PAD Patient Population:
- At least 18 years of age
Show all 9Show fewer
- Evidence of significant obstructive disease for one or multiple lower extremity arteries, as identified by CT angiography, ultrasound, or MR imaging or an abnormal ankle-brachial index or toe-brachial index
- Previously diagnosed diabetes mellitus (type I or II), based on any of the following criteria: fasting plasma glucose great than 126 mg/dl on 2 separate occasions, glycated hemoglobin (HbA1c) greater than 6.5% on 2 separate occasions, fasting plasma glucose greater than 200 mg/dl 2 hours following an oral glucose tolerance test on 2 separate occasions, or fasting plasma glucose and HbA1c above normal limits on same visit.
- scheduled for revascularization due to obstructive blood flow in the lower extremities.
Who cannot join
- Unable to give informed consent
- Enrolled in another trial
- Preexisting medical conditions affecting the vascular system including, but not limited to: Coronary Artery Disease, Peripheral Arterial Disease, diabetes, cancer, hypertension, history of smoking
- Pregnant or nursing
- Unable to give informed consent or follow-up
- Enrolled in another trial
- Exclusion Criteria for patients undergoing clinically indicated myocardial perfusion study:
- 1) Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: SPECT/CT Imaging of Skeletal Muscle Perfusion in Healthy Control Subjects and Patients With Peripheral Arterial Disease: Pilot Clinical Study
This study will use SPECT/CT imaging to assess the effect of percutaneous revascularization treatments in patients with Peripheral arterial disease and diabetes mellitus, in whom the disease can progress more quickly than in patients without diabetes.
Read the detailed description
Peripheral arterial disease (PAD) is a progressive atherosclerotic disease of the lower limbs that affects 8 to 10 million Americans, and is more prevalent and progresses more quickly in patients with diabetes mellitus (DM). There is a critical need for a standard non-invasive approach to assess response to treatment by three-dimensional (3D) perfusion to vascular territories of the feet in PAD patients. Assessing the response to treatment is particularly important in DM patients, who suffer from poor distal runoff and often require more distal revascularization to achieve limb salvage.
In this clinical study, the investigators will evaluate lower extremity skeletal muscle perfusion in the feet of healthy controls and PAD patients who are undergoing revascularization using conventional sodium iodide SPECT/CT imaging, as well as dynamic SPECT/CT imaging with a unique cadmium zinc telluride (CZT) system.
Healthy control subjects will be recruited from Yale University and the greater New Haven area. In addition to healthy control subjects, 35 PAD patients with previously diagnosed diabetes will be recruited from Vascular Surgery and Interventional Cardiology at Yale-New Haven Hospital. Patients who are undergoing revascularization procedures will be identified and asked to participate in the imaging study prior to their revascularization procedure and will be imaged once again 1-3 days following revascularization, prior to hospital discharge.
Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. They will be injected with a low dose radiotracer. In healthy control subjects, arterial blood will be continuously sampled from the radial artery for calculation of a blood input function and K1 values for foot angiosomes. Additionally, we will sample heated venous "arterialized" blood from a hand vein retrograde to evaluate the potential for heated venous blood in the calculation of a blood input function, thus eliminating the need for arterial access in future PAD patient studies.
- Conditions
- Peripheral Arterial Disease, Diabetes Mellitus
- Being tested
- SPECT/CT imaging following revascularization procedures, SPECT/CT imaging
- Medical subject headings
- Peripheral Arterial Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT/CT imaging following revascularization proceduresDevice
Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. Heated venous blood sampling will be obtained.
SPECT/CT imagingDevice
Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. In addition to heated venous blood sampling, arterial blood will be continuously sampled from the radial artery for calculation of a blood input function and K1 values for foot angiosomes.
| Study group | Role | What they receive |
|---|---|---|
| Participants with PAD | Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. Heated venous blood sampling will be obtained. Receives: Device: SPECT/CT imaging following revascularization procedures | |
| Controls | Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. In addition to heated venous blood sampling, arterial blood will be continuously sampled from the radial artery for calculation of a blood input function and K1 values for foot angiosomes. Receives: Device: SPECT/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of effect of percutaneous revascularization treatment measured by change in lower extremity skeletal muscle perfusion before and after treatment using quantitative SPECT/CT imaging of the lower extremities.
Measured: patients will be assessed prior to the revascularization procedure (baseline) and a second time 1-3 days following revascularization.
Assessment of lower extremity skeletal muscle perfusion in healthy control subjects compared to patients with peripheral arterial disease and diabetes using quantitative SPECT/CT imaging.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startMay 2016
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Responsible party
- Sponsor
- Investigators
- Albert J. Sinusas, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791204
- Sponsor's protocol ID
- 1603017342
- Status last verified
- Feb 2026
- First submitted
- 25 May 2016
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPECT/CT Imaging of Skeletal Muscle Perfusion in Healthy Control Subjects and Patients With Peripheral Arterial Disease: Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT02791204
- Acronym / sponsor ID
- 1603017342
- Conditions
- Peripheral Arterial Disease, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Study start
- May 2016 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 6 Jun 2016 (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 use SPECT/CT imaging to assess the effect of percutaneous revascularization treatments in patients with Peripheral arterial disease and diabetes mellitus, in whom the disease can progress more quickly than in patients without diabetes.
Detailed description
Peripheral arterial disease (PAD) is a progressive atherosclerotic disease of the lower limbs that affects 8 to 10 million Americans, and is more prevalent and progresses more quickly in patients with diabetes mellitus (DM). There is a critical need for a standard non-invasive approach to assess response to treatment by three-dimensional (3D) perfusion to vascular territories of the feet in PAD patients. Assessing the response to treatment is particularly important in DM patients, who suffer from poor distal runoff and often require more distal revascularization to achieve limb salvage.
In this clinical study, the investigators will evaluate lower extremity skeletal muscle perfusion in the feet of healthy controls and PAD patients who are undergoing revascularization using conventional sodium iodide SPECT/CT imaging, as well as dynamic SPECT/CT imaging with a unique cadmium zinc telluride (CZT) system.
Healthy control subjects will be recruited from Yale University and the greater New Haven area. In addition to healthy control subjects, 35 PAD patients with previously diagnosed diabetes will be recruited from Vascular Surgery and Interventional Cardiology at Yale-New Haven Hospital. Patients who are undergoing revascularization procedures will be identified and asked to participate in the imaging study prior to their revascularization procedure and will be imaged once again 1-3 days following revascularization, prior to hospital discharge.
Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. They will be injected with a low dose radiotracer. In healthy control subjects, arterial blood will be continuously sampled from the radial artery for calculation of a blood input function and K1 values for foot angiosomes. Additionally, we will sample heated venous "arterialized" blood from a hand vein retrograde to evaluate the potential for heated venous blood in the calculation of a blood input function, thus eliminating the need for arterial access in future PAD patient studies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with PAD | – | Device: SPECT/CT imaging following revascularization proceduresSubjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. Heated venous blood sampling will be obtained. |
| Controls | – | Device: SPECT/CT imagingSubjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. In addition to heated venous blood sampling, arterial blood will be continuously sampled from the radial artery for calculation of a blood input function and K1 values for foot angiosomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * healthy control subjects will be enrolled for this study. * PAD patients with diabetes who are undergoing revascularization procedures * patients undergoing clinically indicated myocardial perfusion imaging study
Key inclusion criteria (9 listed)
- At least 18 years of age
- Normal (0.9-1.2) Ankle Brachial Index
- Inclusion Criteria for patients undergoing clinically indicated myocardial perfusion study:
- 1) At least 18 years of age 2) scheduled for stress myocardial perfusion imaging study for clinically indicated reason
- At least 18 years of age
Key exclusion criteria (8 listed)
- Unable to give informed consent
- Enrolled in another trial
- Preexisting medical conditions affecting the vascular system including, but not limited to: Coronary Artery Disease, Peripheral Arterial Disease, diabetes, cancer, hypertension, history of smoking
- Pregnant or nursing
- Unable to give informed consent or follow-up
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 |
|---|---|---|
| SPECT/CT imaging following revascularization proceduresSubjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. Heated venous blood sampling will be obtained. | Device | Participants with PAD |
| SPECT/CT imagingSubjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. In addition to heated venous blood sampling, arterial blood will be continuously sampled from the radial artery for calculation of a blood input function and K1 values for foot angiosomes. | Device | Controls |
Primary outcome
Assessment of effect of percutaneous revascularization treatment measured by change in lower extremity skeletal muscle perfusion before and after treatment using quantitative SPECT/CT imaging of the lower extremities.
Time frame: patients will be assessed prior to the revascularization procedure (baseline) and a second time 1-3 days following revascularization.
Assessment of lower extremity skeletal muscle perfusion in healthy control subjects compared to patients with peripheral arterial disease and diabetes using quantitative SPECT/CT imaging.
Time frame: baseline
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 24 Feb 2026.
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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.
Albert J. Sinusas, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Diabetes Mellitus, run by Yale University 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 9 inclusion and 8 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 24 Feb 2026. 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?
Assessment of effect of percutaneous revascularization treatment measured by change in lower extremity skeletal muscle perfusion before and after treatment using quantitative SPECT/CT imaging of the lower extremities. (time frame: patients will be assessed prior to the revascularization procedure (baseline) and a second time 1-3 days following revascularization.). The study lists 2 primary outcomes in all. 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 24 Feb 2026.