Back to resultsBOLD MRI as a Surrogate of Improved Muscle Oxygenation Following Endovascular Therapy for the Treatment of CLI
Primary Purpose
Peripheral Arterial Disease, Critical Limb Ischemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BOLD-MRI
Sponsored by
About this trial
This is an interventional other trial for Peripheral Arterial Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- St. John's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BOLD-MRI
Arm Description
Blood Oxygen Level Dependent (BOLD)-MRI assessment of limb perfusion before and after standard of care endovascular therapy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02601430
Brief Title
BOLD MRI as a Surrogate of Improved Muscle Oxygenation Following Endovascular Therapy for the Treatment of CLI
Official Title
Functional Magnetic Resonance Angiographic Imaging Using Blood Oxygen Level Determination (BOLD) Assessment as a Surrogate of Improved Skeletal Muscle Oxygenation After Endovascular Therapy for the Treatment of Chronic Lower Limb Ischemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This study is a prospective single arm, open label registry to evaluate the feasibility of blood oxygen level dependent (BOLD) magnetic resonance imaging for the assessment of a potentially new functional surrogate of altered lower limb skeletal muscle oxygenation after a successful percutaneous endovascular intervention. Baseline MRI assessment using the BOLD technique will be performed on qualified subjects prior to undergoing a standard of care endovascular therapy. Post-procedure BOLD-MRI assessment will also be performed at 30 days and either 90 or 180 days post-procedure. Post-MR image acquisition processing and analysis will be performed, using pre-determined algorithms, by a core laboratory.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Critical Limb Ischemia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BOLD-MRI
Arm Type
Experimental
Arm Description
Blood Oxygen Level Dependent (BOLD)-MRI assessment of limb perfusion before and after standard of care endovascular therapy.
Intervention Type
Other
Intervention Name(s)
BOLD-MRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Enhanced oxygen reperfusion of the index foot assessed by BOLD MRI before and after endovascular intervention.
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krishna J Rocha-Singh, MD
Organizational Affiliation
St. John's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
12. IPD Sharing Statement
Learn more about this trial
BOLD MRI as a Surrogate of Improved Muscle Oxygenation Following Endovascular Therapy for the Treatment of CLI
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