Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HL089619 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators hypothesize that among people with lower extremity peripheral artery disease (PAD), biomarker levels are higher during time periods immediately preceding an acute coronary event compared to time periods not immediately preceding an acute coronary event. Biomarkers the investigators will study are CRP, SAA, and D-dimer. Biomarkers will be measured at baseline and every two months during follow-up.
The primary aims of this study are as follows. Specific Aim #1. Among participants with PAD who experience an acute coronary event during follow-up, the investigators will determine whether biomarker levels measured immediately prior to the coronary event are higher than levels that do not immediately precede coronary events. Specific Aim #2, Part 1. The investigators will determine whether participants who experience a coronary event (cases) have higher biomarker levels at the visit immediately prior to the event than participants who have not experienced a coronary event (controls) at the time of the case event. Specific Aim #2, Part 2. The investigators will determine whether participants who experience a coronary event (cases) have a greater increase in biomarkers during the time period leading up to the event compared to participants who have not experienced a coronary event (controls).
To achieve these aims, the investigators will enroll up to 650 participants with PAD and follow them prospectively, measuring blood samples every two months, and ascertaining the presence of acute coronary events every two months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAD Participants | PAD participants from among consecutive patients with PAD identified from Chicago area non-invasive vascular laboratories |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| fatal and non-fatal coronary events | Our primary outcome is fatal and non-fatal coronary events. Non-fatal coronary events will be defined as acute myocardial infarction (MI), hospitalizations for unstable angina, and new ECG findings consistent with MI | Every two months for up to three and a half years |
Not provided
Not provided
Inclusion Criteria:
We will also include PAD patients with an ABI > 0.90 who meet any of the following criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
PAD participants from among consecutive patients with PAD identified from Chicago area non-invasive vascular laboratories and vascular surgery, cardiology, general internal medicine, geriatric, and endocrinology clinics.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mary M McDermott, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mt. Sinai Medical Center | Chicago | Illinois | 60608 | United States | ||
| Northwestern University Feinberg School of Medicine |
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood: EDTA plasma, Citrate plasma, serum, whole blood (DNA)* and RNA*. Lower extremity muscle biopsies*
*genetic factors and muscle biopsies are optional study elements
| Chicago |
| Illinois |
| 60611 |
| United States |
| Jesse Brown Veterans Administration Medical Center | Chicago | Illinois | 60612 | United States |
| Rush Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| St. Joseph's Hospital | Chicago | Illinois | 60657 | United States |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |