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Perfusion Imaging for Peripheral Arterial Disease
N/A
Recruiting
Led By Mitchel R Stacy, Ph.D.
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence of significant obstructive disease for one or multiple lower extremity arteries, as identified by prior ABI, TBI, CT angiography, ultrasound, or MR imaging.
At least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test whether radiotracer-based perfusion imaging can help predict clinical outcomes for diabetic patients with PAD undergoing lower extremity revascularization procedures.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Since this trial involves diagnostic imaging, potential side effects may include allergic reactions to contrast agents used during scans, radiation exposure risks, and discomfort or bruising from IV line placement for radiotracers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with blocked arteries in my legs.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Lower extremity perfusion
Secondary outcome measures
Limb salvage
Wound healing
Trial Design
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.
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Who is running the clinical trial?
Nationwide Children's HospitalLead Sponsor
341 Previous Clinical Trials
5,220,314 Total Patients Enrolled
Ohio State UniversityOTHER
830 Previous Clinical Trials
505,552 Total Patients Enrolled
5 Trials studying Diabetes
272 Patients Enrolled for Diabetes
Mitchel R Stacy, Ph.D.Principal InvestigatorNationwide Children's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I have never had peripheral arterial disease.I am unable to understand or follow the study's requirements.I have been diagnosed with blocked arteries in my legs.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: PET/CT perfusion imaging
- Group 2: SPECT/CT perfusion imaging
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant count of this clinical trial?
"Affirmative. Clinicaltrials.gov shows that this study is still in search of participants, having been initially posted on February 17th 2017 and revised as recently as December 7th 2021. 200 individuals are being sought from one research centre for the trial."
Answered by AI
Are there any openings left to join this medical experiment?
"Affirmative. According to the clinicaltrials.gov database, this research is actively seeking participants since its original posting on February 17th 2017 and latest update on December 7th 2021. At present, 200 people are required for enrollment at one site."
Answered by AI
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