Contrast Ultrasound Perfusion Imaging in Peripheral Arterial Disease (PAD)

NCT ID: NCT01377649

Last Updated: 2016-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Age matched control subjects without PAD

No interventions assigned to this group

Patients with PAD

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Jonathan R. Lindner, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00007524

Identifier Type: -

Identifier Source: org_study_id

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