Patient and Provider Assessment of Lipid Management Registry

NCT ID: NCT02341664

Last Updated: 2020-03-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7658 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-02-29

Brief Summary

The purpose of the Patient and Provider Assessment of Lipid Management Registry (PALM) is to gain a better understanding of physicians' cholesterol medication prescribing practices, patient and physician attitudes and beliefs related to cholesterol management, and current utilization of cholesterol-lowering therapies given the new ACC/AHA guideline recommendations. The PALM Registry hopes to allow for the design of ways to improve cholesterol management and decrease the burden of cardiovascular disease (CVD) in the US.

Detailed Description

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.

Conditions

Hyperlipidemia; Hypercholesterolemia; Cardiovascular Disease; Diabetes; Chronic Kidney Disease (CKD); Hypertension; Smoking; Myocardial Infarction (MI); Unstable Angina; Angina; Coronary Artery Disease (CAD); Stroke; Transient Ischemic Attack (TIA); Carotid Stenosis; Peripheral Arterial Disease; Atherosclerosis; Claudication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tracy Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Eric Peterson, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Locations

Cardiology and Medicine Clinic

Little Rock, Arkansas, United States

COR Healthcare

San Pedro, California, United States

Ventura Cardiology Consultants Medical Group, Inc

Ventura, California, United States

Maya Research Center, Inc

Hialeah, Florida, United States

Wellness Clinical Research, LLC

Hialeah Gardens, Florida, United States

Infinity Clinical Research

Plantation, Florida, United States

Midwest Heart and Vascular Specialists, LLC

Overland Park, Kansas, United States

Krishnan Challappa, MD, PSC

Elizabethtown, Kentucky, United States

HealthEast Clinical Trials Office

Saint Paul, Minnesota, United States

Long Island Heart Associates

Mineola, New York, United States

Gotham Cardiovascular Research

New York, New York, United States

New Bern Internal Medicine

New Bern, North Carolina, United States

Detweiler Family Medicine Associates, PC

Lansdale, Pennsylvania, United States

Charleston Internal Medicine, Inc.

Charleston, West Virginia, United States

Countries

United States

References

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Other Identifiers

Pro00058405

Identifier Type: -

Identifier Source: org_study_id