Patient and Provider Assessment of Lipid Management Registry

The PALM registry is a multicenter, observational registry aimed at evaluating how
cholesterol management is applied in current clinical practice. This registry will recruit
approximately 175 sites in the United States to enroll 7,500 patients with cardiovascular
risk factors warranting consideration of lipid-lowering therapies as well as those already on
statin therapy. Enrolling clinicians will include primary care providers, internal medicine
providers, family medicine providers, cardiologists, and endocrinologists. Site selection
will also target geographic diversity to ensure representation from all regions of the U.S.,
including rural and urban areas, as well as from minority populations. This registry is
unique featuring the use of a mobile tablet-based enrollment device. This tablet-based
enrollment tool is designed to adapt to the workflow of an outpatient practice, allowing
research procedures (including screening, informed consent and patient survey) to be carried
out during the patient visit, and maximizes paper-less data entry. All patient management
decisions (including the choice of cholesterol-lowering therapy) are completely at the
discretion of the care providers. This registry will involve retrospective and prospective
patient data collection. Baseline data from patients and physicians will be collected. There
will be no patient follow-up.

The target sample size (n=7,500) in this registry is not determined based on statistical
considerations, but is based upon a non-probabilistic sampling approach, in order to obtain
sufficient exposure data in patients who are in the various atherosclerotic cardiovascular
disease (ASCVD) risk groups. During the enrollment period, balance across groups will be
maintained by frequent monitoring of enrollment. Adaptive enrollment and capping will be
considered to ensure adequate exposure across groups, physician type, and geographic
location. Data quality will be assured by web-based or application-based data collection tool
queries and data quality reports . Data quality control measures will include: data entry
missing and range checks, data validation checks; standard record level checks that are run
on the database to identify suspected duplicate, blank, or missing records; and logic checks
and data surveillance of trends in data entry and query processing. The tools will prompt
user to correct any missing, out of range, or potentially incorrect data. There are no
interventions, no outside monitoring of sites nor a DSMB with this registry.

Inclusion Criteria:

1. Prior evidence of clinical atherosclerotic cardiovascular disease (ASCVD) which can
include any of the following:

- Hospitalization for acute myocardial infarction or unstable angina

- Coronary revascularization or chronic coronary artery disease with or without
angina

- Other arterial (carotid, abdominal, renal or lower extremity) revascularization
(e.g., surgical bypass, percutaneous intervention, arterial vascular
reconstruction, abdominal aortic aneurysm repair, excluding dialysis fistulas or
arteriovenous grafts).

- Ischemic stroke or transient ischemic attack (TIA)

- Imaging evidence of > 70% diameter stenosis in any carotid artery or clinical
documentation of severe carotid stenosis

- Peripheral arterial disease secondary to atherosclerosis (e.g., aortic aneurysm,
ankle brachial index <0.9, imaging evidence of >50% diameter stenosis in any
peripheral artery, or claudication)

2. Currently on statin therapy

3. Low density lipoprotein cholesterol (LDL-C) level ≥ 130 mg/dL within the last 2 years
(treated or untreated)

4. Age ≥ 65 years

5. Age ≥ 40 years with at least 1 of the following:

- Diabetes

- Chronic Kidney Disease (CKD), defined as eGFR <60 ml/min or documented stage III
or higher CKD

- 10-year ASCVD risk ≥ 5% (per the 2013 ACC/AHA Guideline on the Assessment of
Cardiovascular Risk)

- 2 or more of the following characteristics: Male sex; Systolic BP > 140 mmHg or
on medication for hypertension; Current tobacco use

Exclusion Criteria:

1. Unable or unwilling to provide informed consent, including but not limited to
cognitive or language barriers (reading or comprehension)

2. Anticipated life expectancy less than 6 months

3. Participation in any clinical trial involving a medical treatment at the time of
enrollment