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Contrast Ultrasound Perfusion Imaging in Peripheral Arterial Disease (PAD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jonathan R. Lindner, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01377649
First received: June 20, 2011
Last updated: September 26, 2016
Last verified: September 2016
  Purpose
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
Peripheral Arterial Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contrast Ultrasound Perfusion Imaging in Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Quantitation of Perfusion [ Time Frame: Immediate ] [ Designated as safety issue: No ]
    Correlation of skeletal muscle perfusion with symptom status


Enrollment: 18
Study Start Date: July 2011
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
Age matched control subjects without PAD
Patients with PAD

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: June 20, 2011
Last Updated: September 26, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on December 02, 2016