Micro- and Macrovascular Adaptations in Patients With Peripheral Arterial Disease During Supervised Exercise Therapy (VAPAV)

Maastricht University Medical Centre (MUMC)

Status: Unknown

Conditions: PAOD (Peripheral Arterial Obstructive Disease)

Treatments: Other: supervised treadmill exercise program

Study type: Observational

Funder types: Other

Identifiers

NCT00675402

MEC 08-2-032

Details and patient eligibility

About

Given that previous studies demonstrated the feasibility of the required MRI techniques, we propose to study the macro- and microvascular adaptations in PAOD patients undergoing supervised exercise therapy. It is expected to provide valuable insights into the contribution of each vascular mechanism to the rehabilitation and to identify which vascular mechanism fails or is insufficient for a successful rehabilitation. Improvement of future treatment requires the identification of relevant adaptive mechanisms. With this we will provide early noninvasive MRI readout tools to diagnose and monitor the potential rehabilitation during any form of therapy for PAOD that affects the peripheral vasculature.

Enrollment: 117 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Intermittent claudication according to a positive Rose-Edingburgh questionnaire
• Rest ankle-brachial pressure index (ABPI) < 0,90 or 10% decline in ABPI after exercise
• Arterial stenosis/occlusion of femoro-popliteal territory according to duplex/MRA measurements
• Able to ondergo exercise therapy

Exclusion criteria

• Chronic or acute critical ischemia
• Treated by or planned for vascular surgery or percutaneous transluminal angioplasty
• Recent onset <2 months
• Unable to perform treadmill exercise
• Diabetes mellitus
• Contra-indications for (Gadolinium-enhanced) MRI or thigh cuff inflation

Trial design

117 participants in 1 patient group

1

Description:

Patients referred to the vascularsurgeon with complaints of claudication for their first time, will be asked to participate with the study, with respect toward the in- and exclusion criteria.

Treatment:

Other: supervised treadmill exercise program