Contrast Ultrasound Perfusion Imaging in Peripheral Arterial Disease (PAD)

NCT01377649 | Completed DMC

• 1 other identifier: IRB00007524
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Quantitation of Perfusion

  Correlation of skeletal muscle perfusion with symptom status

  Immediate

Study Arms (2)

Control

Age matched control subjects without PAD

Patients with PAD

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with peripheral arterial disease who are referred for diagnostic angiography and/or revascularization procedures

You may qualify if:

• Known or suspected PAD
• Lower extremity angiography or MRA planned or performed within 6 months

You may not qualify if:

• Age \<19 y.o.
• Pregnant or lactating females
• Hypersensitivity to ultrasound contrast agent, dipyridamole, or regadenoson
• Severe reactive airways disease
• Evidence right-to-left shunt (identified on screening echo)
• NYHA Class III or IV heart failure.
• Planned amputation
• Unstable coronary artery disease or severe aortic stenosis

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 21, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

US (1)