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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601430
• Other study ID #: BB-BOLD-15
• Status: Completed
• Phase: N/A
• First received: October 30, 2015
• Last updated: October 11, 2017
• Start date: February 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• BOLD-MRI
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.

Locations

Country	Name	City	State
United States	St. John's Hospital	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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