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NCT01377649 Clinical Trial

Contrast Ultrasound Perfusion Imaging in Peripheral Arterial Disease (PAD)

Peripheral Arterial Disease Clinical Trial

Official title:
Contrast Ultrasound Perfusion Imaging in Peripheral Arterial Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01377649
Other study ID # IRB00007524
Secondary ID
Status Completed
Phase N/A
First received June 20, 2011
Last updated September 26, 2016
Start date July 2011
Est. completion date September 2016

Study information
Verified date September 2016
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Contrast ultrasound is a technique that can quantify blood flow in the tissues of the body by ultrasound detection of microbubble contrast agents that behave in the circulation similar to red blood cells. In this study, the investigators hypothesize that contrast ultrasound of blood flow in the leg (thigh and calf) at rest and during stress produced by medications that mimic exercise (vasodilator stress) can provide information on the location and severity of peripheral vascular disease (blockages of the blood vessels in the leg). The investigators will also determine whether symptom improvement after revascularization (procedures to open up or bypass the blockages) is directly related to the improvement in blood flow.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

1. Known or suspected PAD

2. Lower extremity angiography or MRA planned or performed within 6 months

Exclusion Criteria:

1. Age <19 y.o.

2. Pregnant or lactating females

3. Hypersensitivity to ultrasound contrast agent, dipyridamole, or regadenoson

4. Severe reactive airways disease

5. Evidence right-to-left shunt (identified on screening echo)

6. NYHA Class III or IV heart failure.

7. Planned amputation

8. Unstable coronary artery disease or severe aortic stenosis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quantitation of Perfusion Correlation of skeletal muscle perfusion with symptom status Immediate No
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