BOLD MRI as a Surrogate of Improved Muscle Oxygenation Following Endovascular Therapy for the Treatment of CLI

NCT02601430 | Completed

• 1 other identifier: BB-BOLD-15
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if an MRI technique called Blood Oxygen Level Dependent, or BOLD, can be used to evaluate blood flow in the leg before and after treatment with standard endovascular therapy in patients with chronic lower limb ischemia.

Conditions

Peripheral Arterial Disease; Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• Enhanced oxygen reperfusion of the index foot assessed by BOLD MRI before and after endovascular intervention.

  The BOLD MR T2\* signal will be analyzed pre-and post-endovascular intervention to determine if it is able to detect a difference in foot oxygen perfusion levels.

  6 months

Study Arms (1)

BOLD-MRI

EXPERIMENTAL

Blood Oxygen Level Dependent (BOLD)-MRI assessment of limb perfusion before and after standard of care endovascular therapy.

Other: BOLD-MRI

Interventions

BOLD-MRI OTHER

A fixed air cuff will be placed on the index limb at the level of the calf and will be inflated to a level which induces the loss of the pedal Doppler signal. Inflation will be maintained for 180 seconds, then will be rapidly deflated and BOLD MR imaging will be initiated.

BOLD-MRI

Eligibility Criteria

• Age: 19 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 and \< 90 years
• Subject has been informed of the nature of the study and agreed to participate and has signed an IRB approved consent form
• Subject understands the duration of the study and its follow-up visit requirements and agrees to comply
• Subject has documented chronic limb ischemia in the target limb with Rutherford Category 2-5 and pulse plethysmography (PPG), pulse volume recording (PVRs), TcPO2, ABIs or toe pressures and symptoms that conform to the diagnosis of life-style limiting claudication or critical limb ischemia

You may not qualify if:

• Adult subjects who lack the capacity to consent for themselves
• Women who are pregnant or wish to become pregnant during the course of the study. (Women of child-bearing potential must undergo pregnancy testing at the time of enrollment, and be counseled in appropriate measures to avoid becoming pregnant for the duration of the study)
• Subjects with contraindications to MR imaging procedures (including the administration of gadolinium based contrast agents)
• Subjects suspected to be unable to withstand the reactive hyperemia protocol

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

St. John's Hospital

Springfield, Illinois, 62701, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Krishna J Rocha-Singh, MD

  St. John's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 10, 2015
• Study Start: February 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 12, 2017

Record last verified: 2017-10

Locations

US (1)