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Patient and Provider Assessment of Lipid Management Registry (PALM)

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ClinicalTrials.gov Identifier: NCT02341664
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : February 17, 2016
Sponsor:
Collaborators:
Regeneron Pharmaceuticals
Sanofi
Information provided by (Responsible Party):
Duke University

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.

Condition or disease
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

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.


Study Type : Observational [Patient Registry]
Actual Enrollment : 7658 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Patient and Provider Assessment of Lipid Management Registry
Study Start Date : May 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016



Primary Outcome Measures :
  1. Lipid-lowering therapy use among a contemporary, nationally representative, community-based sample of adult patients receiving primary and subspecialty care in the US. [ Time Frame: baseline, upon enrollment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This registry will recruit approximately 175 sites to enroll ~7,500 patients with cardiovascular risk factors warranting consideration of lipid-lowering therapies as well as those already on statin therapy. Patients will be recruited from outpatient clinics including primary care, internal medicine, family medicine, cardiology, and endocrinology. Patients will be recruited across all regions of the U.S., including rural and urban areas, as well as from minority populations.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341664


Locations
United States, Arkansas
Cardiology and Medicine Clinic
Little Rock, Arkansas, United States, 72204
United States, California
COR Healthcare
San Pedro, California, United States, 90732
Ventura Cardiology Consultants Medical Group, Inc
Ventura, California, United States, 93003
United States, Florida
Wellness Clinical Research, LLC
Hialeah Gardens, Florida, United States, 33016
Maya Research Center, Inc
Hialeah, Florida, United States, 33013
Infinity Clinical Research
Plantation, Florida, United States, 33317
United States, Kansas
Midwest Heart and Vascular Specialists, LLC
Overland Park, Kansas, United States, 66209
United States, Kentucky
Krishnan Challappa, MD, PSC
Elizabethtown, Kentucky, United States, 42701
United States, Minnesota
HealthEast Clinical Trials Office
St Paul, Minnesota, United States, 55102
United States, New York
Long Island Heart Associates
Mineola, New York, United States, 11501
Gotham Cardiovascular Research
New York, New York, United States, 10001
United States, North Carolina
New Bern Internal Medicine
New Bern, North Carolina, United States, 28562
United States, Pennsylvania
Detweiler Family Medicine Associates, PC
Lansdale, Pennsylvania, United States, 19446
United States, West Virginia
Charleston Internal Medicine, Inc.
Charleston, West Virginia, United States, 25304
Sponsors and Collaborators
Duke University
Regeneron Pharmaceuticals
Sanofi
Investigators
Principal Investigator: Tracy Wang, MD Duke Clinical Research Institute
Principal Investigator: Eric Peterson, MD Duke Clinical Research Institute

Publications:
Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. Erratum in: Circulation. 2015 Dec 22;132(25):e396. Circulation. 2014 Jun 24;129(25 Suppl 2):S46-8.
Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB, Gibbons R, Greenland P, Lackland DT, Levy D, O'Donnell CJ, Robinson JG, Schwartz JS, Shero ST, Smith SC Jr, Sorlie P, Stone NJ, Wilson PW, Jordan HS, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S49-73. doi: 10.1161/01.cir.0000437741.48606.98. Epub 2013 Nov 12. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S74-5.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02341664     History of Changes
Other Study ID Numbers: Pro00058405
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: January 2016

Keywords provided by Duke University:
Mobile Tablet Device
Outpatient Clinic
Tobacco
Health
Barriers
Prevention
Prescribing Practices
Informed Consent
Statin
Lipid Panel
Low Density Lipoprotein-C
Blood Draw
ACC/AHA Guidelines
Adult Treatment Panel Guidelines (ATPIII)
Atherosclerotic Cardiovascular Disease (ASCVD)
Cholesterol-lowering therapies
Cholesterol Management
Cardiovascular Risk
10-year CVD Risk
Labs
Coronary revascularization
Arterial revascularization
Imaging

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Kidney Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Renal Insufficiency, Chronic
Atherosclerosis
Hypercholesterolemia
Angina Pectoris
Peripheral Arterial Disease
Peripheral Vascular Diseases
Hyperlipidemias
Hyperlipoproteinemias
Ischemic Attack, Transient
Angina, Unstable
Carotid Stenosis
Ischemia
Pathologic Processes
Necrosis
Urologic Diseases
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Renal Insufficiency
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases