Contrast Ultrasound Perfusion Imaging in Peripheral Arterial Disease (PAD)

Contrast Ultrasound Perfusion Imaging in Peripheral Arterial Disease

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control; Age matched control subjects without PAD
Patients with PAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitation of Perfusion	Correlation of skeletal muscle perfusion with symptom status	Immediate

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: June 20, 2011
• First Submitted That Met QC Criteria: June 20, 2011
• First Posted (Estimate): June 21, 2011

Study Record Updates

• Last Update Posted (Estimate): September 27, 2016
• Last Update Submitted That Met QC Criteria: September 26, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: IRB00007524