Coronary Artery Disease, Peripheral Artery Disease
Conditions
Brief summary
Peripheral artery disease, lack or blood flow to the legs, has a high prevalence in the Veteran population. In patients with severe peripheral artery disease that requires an endovascular or surgical intervention for lower leg revascularization, the long-term mortality of approximately 50% is worse that most cancers. The goal of this study is to develop a management strategy to improve cardiovascular outcomes in this high-risk peripheral artery disease population after lower extremity revascularization.
Detailed description
This study will be to conduct a randomized, controlled, multi-center clinical trial to evaluate a non-invasive management strategy of a computed topography (CT) scan of the coronary arteries and computational analysis of coronary perfusion with selective coronary revascularization plus optimal medical therapy compared to optimal medical therapy. Therefore, this study will provide the opportunity for Veterans to participate in a clinical trial to reduce the very high cardiac-related mortality rate in this population.
Interventions
DIAGNOSTIC_TESTCoronary computed topography (CT) angiography with FFR-CT
The investigational treatment strategy will have a coronary CT angiography diagnostic imaging with computational analysis FFR-CT (Fractional Flow Reserve from the coronary CTA)
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This will be a parallel interventional model to assign participants to a treatment strategy in a clinical study
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male or female 50 to 85 * Severe intermittent claudication with ABI \< 0.6 or monophasic waveform if non-compressible and TBI \< 0.6 * Chronic limb threatening ischemia (CLTI) with pain at rest (Rutherford Category 4) with ABI \< 0.5 or TBI \< 0.6 * CLTI with minor tissue loss (Rutherford Category 5) with ABI \< 0.5 or TBI \< 0.6 * Completed Lower Extremity Revascularization and enrolled within 45 days * The patient or legal representative will provide informed written consent * The patient has a life expectancy of at least 1 year
Exclusion criteria
* Major tissue loss of the ischemic limb (Rutherford Category 6) * Uncompensated congestive heart failure (NYHA class IV) * Myocardial infarction or stroke within the past 90 days * Prior coronary artery bypass graft (CABG) revascularization surgery * Prior percutaneous coronary intervention (PCI) with angioplasty or stenting * Presence of a pacemaker * Congestive heart failure with Ejection Fraction \< 30% * Elevated liver function tests more than twice the upper limit of normal * Severe Chronic renal disease (Glomerular Filtration Rate, GFR \< 30) or on hemodialysis * Pregnancy, Human Immunodeficiency Virus, or organ transplant recipients * Current malignancy or malignancy within the last two years unless the treating oncologic physician provides prognosis of an anticipated 2- year survival (i.e., adequately treated non-melanoma skin cancer or adequately treated prostate cancer without metastatic disease) * Any condition the review panel determines would make the patient unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events (MACE) | 2 years | cardiovascular-related death or myocardial infarction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular-related death | 2 years | death related to cardiovascular disease (i.e., heart attack) |
| Myocardioal infarction | 2 years | heart attack |
| All-cause mortality | 2 years | death related to any cause |
| Amputation-free survival | 2 years | freedom from major amputation |
Countries
United States
Outcome results
None listed