Perfusion Imaging for Peripheral Arterial Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Nationwide Children's Hospital
Disqualifiers: Pregnant, Nursing, Under 18, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The aim of this clinical study is to 1) establish a healthy database for nuclear perfusion imaging of the lower extremities and 2) assess the prognostic value of radiotracer-based perfusion imaging for predicting clinical outcomes in patients with peripheral artery disease (PAD) who are undergoing lower extremity revascularization procedures. We hypothesize that radiotracer imaging of the lower extremities will provide a sensitive non-invasive imaging tool for quantifying regional abnormalities in skeletal muscle perfusion and evaluating responses to medical treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment PET/CT perfusion imaging for Peripheral Arterial Disease?
Research shows that PET myocardial perfusion imaging (MPI) is more accurate and uses lower radiation doses compared to SPECT MPI for detecting coronary artery disease, which suggests it could be effective for other conditions like Peripheral Arterial Disease. Additionally, combining PET with CT can improve diagnostic accuracy by assessing both anatomy and blood flow.12345
Is perfusion imaging safe for humans?
Perfusion imaging, including methods like SPECT and CT, is generally considered safe for humans, with mild and rare adverse events reported in studies. However, there can be serious complications under certain conditions, and the safety may vary depending on the patient's risk factors and the specific imaging method used.678910
How does perfusion imaging differ from other treatments for peripheral arterial disease?
Perfusion imaging for peripheral arterial disease is unique because it provides detailed information about blood flow and the physiological impact of arterial blockages, which helps in treatment planning. Unlike traditional methods, it offers a non-invasive way to assess how well blood is reaching different parts of the leg, complementing other diagnostic tools like arteriography.1112131415
Eligibility Criteria
This trial is for adults over 18 with peripheral arterial disease (PAD), specifically diabetic patients needing lower extremity revascularization. They must have evidence of significant artery blockage in the legs, confirmed by previous medical imaging tests.Inclusion Criteria
I have been diagnosed with blocked arteries in my legs.
I am 18 years old or older.
Exclusion Criteria
I am under 18 years old.
Pregnant or nursing
I have never had peripheral arterial disease.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
1 visit (in-person)
Imaging
Participants undergo SPECT/CT or PET/CT perfusion imaging before and 1-14 days after revascularization
2 weeks
2 visits (in-person)
Follow-up
Participants are monitored for clinical outcomes such as wound healing and limb salvage
12 months
Periodic follow-up visits
Treatment Details
Interventions
- PET/CT perfusion imaging (Diagnostic Test)
- SPECT/CT perfusion imaging (Diagnostic Test)
Trial OverviewThe study is testing two types of perfusion imaging: SPECT/CT and PET/CT to see how well they predict outcomes after leg blood flow restoration procedures in PAD patients. It aims to evaluate if these scans can effectively assess muscle blood supply issues and monitor treatment success.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: SPECT/CT perfusion imagingExperimental Treatment2 Interventions
Patients with peripheral artery disease will have already been scheduled for clinically indicated revascularization procedures of the lower extremity and undergo SPECT/CT imaging as part of the research protocol.
Group II: PET/CT perfusion imagingExperimental Treatment2 Interventions
Patients with peripheral artery disease will have already been scheduled for clinically indicated revascularization procedures of the lower extremity and undergo PET/CT imaging as part of the research protocol.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Nationwide Children's HospitalColumbus, OH
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Who Is Running the Clinical Trial?
Nationwide Children's HospitalLead Sponsor
Ohio State UniversityCollaborator
References
The Potential of F-18 Flurpiridaz PET/CT Myocardial Perfusion Imaging for Precision Imaging. [2022]Myocardial perfusion imaging (MPI) with single photon emission computed tomography (SPECT) has been the main method for assessing patients with known or suspected coronary artery disease (CAD) for decades. Based on a strong and growing evidence base, positron emission tomography (PET) MPI is increasingly favored when it is available. However, currently available PET perfusion tracers have limitations that have hampered broad utilization.
Cardiac image fusion from stand-alone SPECT and CT: clinical experience. [2022]Myocardial perfusion imaging with SPECT (SPECT-MPI) and 64-slice CT angiography (CTA) are both established techniques for the noninvasive evaluation of coronary artery disease (CAD). Three-dimensional (3D) SPECT/CT image fusion may offer an incremental diagnostic value by integrating both sets of information. We report our first clinical experiences with fused 3D SPECT/CT in CAD patients.
Myocardial perfusion imaging with PET. [2021]PET-myocardial perfusion imaging (MPI) allows accurate measurement of myocardial perfusion, absolute myocardial blood flow and function at stress and rest in a single study session performed in approximately 30 min. Various PET tracers are available for MPI, and rubidium-82 or nitrogen-13-ammonia is most commonly used. In addition, a new fluorine-18-based PET-MPI tracer is currently being evaluated. Relative quantification of PET perfusion images shows very high diagnostic accuracy for detection of obstructive coronary artery disease. Dynamic myocardial blood flow analysis has demonstrated additional prognostic value beyond relative perfusion imaging. Patient radiation dose can be reduced and image quality can be improved with latest advances in PET/CT equipment. Simultaneous assessment of both anatomy and perfusion by hybrid PET/CT can result in improved diagnostic accuracy. Compared with SPECT-MPI, PET-MPI provides higher diagnostic accuracy, using lower radiation doses during a shorter examination time period for the detection of coronary artery disease.
Improved Performance of PET Myocardial Perfusion Imaging Compared to SPECT in the Evaluation of Suspected CAD. [2023]Myocardial perfusion imaging (MPI) with single photon emission computed tomography (SPECT) has played a central role in the non-invasive evaluation of patients with obstructive coronary artery disease (CAD) for decades. In this review, we discuss the key differences and advantages of positron emission tomography (PET) MPI over SPECT MPI as it relates to the diagnosis, prognosis, as well as clinical decision-making in patients with suspected CAD.
CT imaging of myocardial perfusion: possibilities and perspectives. [2021]Functional imaging in patients with suspected or known coronary artery disease (CAD) is crucial for the identification of patients who could benefit from coronary revascularization. Several studies demonstrated the high diagnostic accuracy of Single-photon-emission computed tomography myocardial perfusion imaging, stress perfusion magnetic resonance imaging, and of invasive FFR measurements for the detection of hemodynamic relevant stenosis. Cardiac computed tomography (CT) used to be limited to coronary angiography (CTA); current guidelines recommend CTA only for the exclusion of CAD. Technological advances now offer the possibility to assess myocardial perfusion by computed tomography (CT-MPI). Though different acquisition protocols and post-processing algorithms still have to be evaluated, initial clinical studies could already show a diagnostic accuracy comparable to the established imaging modalities. Thus, cardiac CT may offer a combined approach of anatomical and functional imaging. Beside the need for further studies, especially on the prognostic value of CT-MPI to stratify future cardiovascular events, the comparatively high radiation exposure and additional administration of contrast agent has to be taken in account.
A case report: adenosine triggered myocardial infarction during myocardial perfusion stress test imaging in a diabetic patient. [2022]Myocardial perfusion imaging (MPI) using single-photon emission computed tomography (SPECT) can in general be used safely in daily clinical practice. However, under the right circumstances, it can lead to serious complications.
Ambulatory cardiac single-photon emission computed tomography at the primary care physician's office: a descriptive study. [2010]Ambulatory cardiac single-photon emission computed tomography stress testing for the evaluation of coronary artery disease at the primary care physician's office is increasingly utilized without data supporting its safety. In this 2-year prospective pilot study of 1266 consecutive stress-myocardial perfusion imaging studies done in the primary care physician's office using a mobile nuclear cardiology laboratory, adverse events were mild and rare. There were no recorded events of myocardial infarction, serious arrhythmias, severe bronchospasm, hospitalization, or death. This suggests that this practice is safe in this population with these providers. This finding may not apply to a higher-risk population. Further evaluation of referral appropriateness and long-term prognostic value is needed.
Predictors and Diagnostic Significance of the Adenosine Related Side Effects on Myocardial Perfusion SPECT/CT Imaging. [2023]The aim of this study was to investigate the relationship between patient characteristics and adenosine-related side-effects during stress myocard perfusion imaging (MPI). The effect of presence of adenosine-related side-effects on the diagnostic value of MPI with integrated SPECT/CT system for coronary artery disease (CAD), was also assessed in this study.
Diagnostic safety of a machine learning-based automatic patient selection algorithm for stress-only myocardial perfusion SPECT. [2023]Stress-only myocardial perfusion imaging (MPI) markedly reduces radiation dose, scanning time, and cost. We developed an automated clinical algorithm to safely cancel unnecessary rest imaging with high sensitivity for obstructive coronary artery disease (CAD).
Current status of cardiac CT for the detection of myocardial ischemia. [2021]Stress and rest myocardial perfusion imaging using computed tomography (CT) can be accurately and safely performed. CT angiography allows for the anatomic visualization of coronary lesions and the components of atherosclerotic plaque, whereas according to currently available data, CT perfusion imaging improves the diagnostic accuracy for detecting ischemic lesions. However, the radiation exposure and contrast load that are involved cannot be neglected. Owing to the limited number of trials that have been published so far, and the fact that they used a wide variety of image acquisition and stress protocols, a standard acquisition protocol for CT perfusion imaging still needs to be found and evaluated in larger multicenter trials. Therefore, CT perfusion imaging, as opposed to other modalities such as magnetic resonance perfusion, SPECT, or positron emission tomography, cannot yet be regarded as clinical routine, but may be considered in patients with contraindications for other imaging modalities.
Unenhanced Velocity-Selective MR Angiography (VS-MRA): Initial Clinical Evaluation in Patients With Peripheral Artery Disease. [2023]Safe and accurate imaging of the peripheral arterial system is important for diagnosis and treatment planning of patients with peripheral artery disease (PAD).
Peripheral MR angiography. [2009]Imaging of the arteries of the lower extremity is most often performed in patients who have known or suspected peripheral artery occlusive disease. Due to the recent advances in imaging modalities, the radiologic approach to the diagnosis of peripheral artery occlusive disease has changed substantially in the last few years. Recent technical developments such as the introduction of new image reconstruction algorithms and dedicated contrast agents have pushed the limits of MR angiography toward higher spatial resolution and image quality and have enabled time-resolved imaging. This article discusses various techniques of peripheral MR angiography, including step-by-step, hybrid, continuous table movement, and non-contrast-enhanced MR angiography.
Multimodality imaging approach for serial assessment of regional changes in lower extremity arteriogenesis and tissue perfusion in a porcine model of peripheral arterial disease. [2021]A standard quantitative imaging approach to evaluate peripheral arterial disease does not exist. Quantitative tools for evaluating arteriogenesis in vivo are not readily available, and the feasibility of monitoring serial regional changes in lower extremity perfusion has not been examined.
Peripheral vascular perfusion scanning. Correlation with the arteriogram and clinical assessment in the patient with peripheral vascular disease. [2019]Peripheral vascular perfusion scan during rest and reactive hyperemia does not necessarily offer the same information as the arteriogram or the clinical assessment of the peripheral pulses. The information obtained from the peripheral vascular perfusion scan offers potentially clinically useful information regarding the physiologic significance of various arterial lesions to the surgeon in selection of his therapeutic approach. The peripheral vascular perfusion scan uniquely and under varied physiologic conditions permits assessment of the effect of arterial disease on the distribution of perfusion within the extremity. The peripheral vascular perfusion scan is not in competition with, but is complementary to, arteriography and clinical assessment of the patient with peripheral vascular disease.
Topographical evaluation of skin perfusion patterns in peripheral arterial occlusive disease by means of computer-assisted fluorescein perfusography. [2019]To evaluate the clinical impact of computer-assisted fluorescein perfusography in peripheral arterial occlusive disease (PAOD).