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Contrast Ultrasound Perfusion Imaging in Peripheral Arterial Disease (PAD)

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ClinicalTrials.gov Identifier: NCT01377649
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Peripheral Arterial Disease

Study Design

Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contrast Ultrasound Perfusion Imaging in Peripheral Arterial Disease
Study Start Date : July 2011
Primary Completion Date : September 2016
Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Quantitation of Perfusion [ Time Frame: Immediate ]
    Correlation of skeletal muscle perfusion with symptom status


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with peripheral arterial disease who are referred for diagnostic angiography and/or revascularization procedures
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377649


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
More Information

Responsible Party: Jonathan R. Lindner, MD, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01377649     History of Changes
Other Study ID Numbers: IRB00007524
First Posted: June 21, 2011    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases