Ignite Creation Date:
2025-12-25 @ 3:36 AM
Ignite Modification Date:
2026-04-13 @ 11:42 PM
Study NCT ID:
NCT06488105
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2024-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '130 Emergency Department patients will be randomized with chest pain 1:1 to Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) or usual care.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2024-06-28', 'studyFirstSubmitQcDate': '2024-06-28', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in low-density lipoprotein cholesterol (LDL-C) at 30 days', 'timeFrame': 'Index ED encounter through 30 days (-3, +11 days)', 'description': 'Percent change in LDL-C from the index Emergency Department (ED) encounter through 30 days'}], 'secondaryOutcomes': [{'measure': 'Percent change in LDL-C at 180 days.', 'timeFrame': 'Index ED encounter through 180 days (+/- 15 days)', 'description': 'Percent change in LDL-C from the index ED encounter through 180 days'}, {'measure': 'Percent change in non high-density lipoprotein cholesterol (non-HDL-C) at 30 days', 'timeFrame': 'Index ED encounter through 30 days (-3, +11 days)', 'description': 'Percent change in non-HDL-C from the index ED encounter through 30 days'}, {'measure': 'Percent change in non-HDL-C at 180 days', 'timeFrame': 'Index ED encounter through 180 days (+/- 15 days)', 'description': 'Percent change in non-HDL-C from the index ED encounter through 180 days'}, {'measure': 'Proportion of patients with outpatient clinic follow-up at 30 days', 'timeFrame': 'Index ED encounter through 30 days (-3, +8 days)', 'description': 'Did the patient follow-up with the recommended outpatient care team?'}, {'measure': 'Proportion of patients with statin prescription pick-up', 'timeFrame': 'Index ED encounter through 10 days', 'description': 'Did the patient pick-up their statin prescription from the pharmacy?'}, {'measure': 'Qualitative barriers and facilators', 'timeFrame': '30 days (+30 days) after the index ED encounter', 'description': 'Qualitative interviews to determine facilitators and barriers to the Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) program'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hyperlipidemia', 'cardiovascular disease', 'atherosclerotic cardiovascular disease'], 'conditions': ['Lipid Disorder', 'Hypercholesterolemia', 'Cardiovascular Diseases', 'Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) is a protocolized intervention based on American College of Cardiology/American Heart Association and US Preventive Services Task Force guidelines designed to initiate preventive cardiovascular care for emergency department patients being evaluated for acute coronary syndrome. The overarching goals of this proposal are to (1) determine the efficacy of EMERALD at lowering low-density lipoprotein cholesterol (LDL-C) and non high-density lipoprotein cholesterol (non-HDL-C) among at-risk Emergency Department (ED) patients who are not already receiving guideline-directed outpatient preventive care and (2) inform our understanding of patient adherence and determinants of implementation for ED-based cardiovascular disease prevention strategies.', 'detailedDescription': 'EMERALD involves (1) ordering an ED lipid panel, (2) calculating 10-year atherosclerotic cardiovascular disease (ASCVD) risk, (3) prescribing a moderate- or high-intensity statin, (4) providing healthy lifestyle counseling, and (5) bridging patients to ongoing outpatient preventive care (primary care or cardiology, depending on risk level).\n\nWe hypothesize that EMERALD will be associated with lower LDL-C and non-HDL-C at 30- and 180-days vs. usual care. The primary outcome will be percent change in LDL-C at 30-days. Secondary outcomes include percent change in LDL-C at 180-days and non-HDL-C at 30- and 180-days. We will randomize 130 ED patients with possible acute coronary syndrome 1:1 to EMERALD or usual care, which will provide 90% power with a two-sided alpha of 0.05 to demonstrate a 10% difference in percent change in LDL-C at 30-days between arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Evaluation for Acute Coronary Syndrome\n2. Age 40-75 Years\n3. 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk ≥7.5% or Known Diabetes or\n\nKnown ASCVD:\n\n1. Myocardial Infarction\n2. Unstable Angina\n3. Percutaneous Coronary Intervention\n4. Coronary Artery Bypass Graft\n5. Stroke\n6. Transient Ischemic Attack\n7. Peripheral Artery Disease\n\nExclusion Criteria\n\n1. ST-Segment Elevation Myocardial Infarction (STEMI) Activation\n2. ST Depression \\>1 mm in Contiguous Leads\n3. On a Lipid Lowering Agent (Statin, PCSK9 Inhibitor, Bempedoic Acid, Ezetimibe, Inclisiran, etc.)\n4. Inability to Return for 30-day Follow-up\n5. Unstable Vitals (Systolic blood pressure \\<90, HR \\>120 or \\<50, oxygen saturation \\<90%)\n6. Statin Intolerance\n7. Any Resulted High-Sensitivity Troponin I ≥100 ng/L\n8. End-stage renal disease (ESRD) and/or glomerular filtration rate (GFR) \\<30 mL/min/1.73 m2\n9. Liver Cirrhosis\n10. Pregnancy\n11. Anticipated Hospitalization\n12. Life Expectancy \\<1 Year\n13. Transfer from Another Hospital\n14. Prisoner\n15. Non-English Speaking'}, 'identificationModule': {'nctId': 'NCT06488105', 'acronym': 'EMERALD RCT', 'briefTitle': 'Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Initiating Preventive Care for Hyperlipidemia in the Emergency Department: The EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) Trial', 'orgStudyIdInfo': {'id': 'IRB00104057'}, 'secondaryIdInfos': [{'id': '1K23HL169929-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K23HL169929-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) arm', 'description': 'In the EMERALD arm, care will vary by risk level: (1) patients with known atherosclerotic cardiovascular disease (ASCVD) will qualify for a high-intensity statin (rosuvastatin 40 mg daily) and referral to cardiology for secondary prevention, (2) patients with low-density lipoprotein cholesterol (LDL-C) ≥190 mg/dL will receive a high-intensity statin and a cardiology referral for primary prevention, and (3) for the remaining patients, Emergency Department providers will calculate 10-year ASCVD risk using the Pooled Cohort Equations. These patients will be categorized as (3A) high risk patients (10-year risk ≥20%) who will receive a high-intensity statin and a cardiology referral and (3B) moderate risk patients (10-year risk ≥7.5% but \\<20% or those with known diabetes and 10-year risk \\<20%) who will receive a moderate-intensity statin (rosuvastatin 10 mg daily) and a primary care referral. EMERALD patients will also receive healthy lifestyle counseling.', 'interventionNames': ['Drug: Statin (rosuvastatin 10 or 40 mg daily, depending on risk)', 'Behavioral: Healthy Lifestyle Counseling', 'Other: Outpatient Followup']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care Arm', 'description': 'Patients in the usual care arm will receive the current standard of care, which consists of primary care referral and no Emergency Department statin prescription. They will also receive healthy lifestyle counseling.', 'interventionNames': ['Behavioral: Healthy Lifestyle Counseling', 'Other: Outpatient Followup']}], 'interventions': [{'name': 'Statin (rosuvastatin 10 or 40 mg daily, depending on risk)', 'type': 'DRUG', 'otherNames': ['Crestor'], 'description': 'moderate- or high-intensity statin (either rosuvastatin 10 mg daily or rosuvastatin 40 mg daily)', 'armGroupLabels': ['Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) arm']}, {'name': 'Healthy Lifestyle Counseling', 'type': 'BEHAVIORAL', 'description': "Healthy lifestyle counseling based off the American Heart Association's Life Essential 8 framework", 'armGroupLabels': ['Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) arm', 'Usual Care Arm']}, {'name': 'Outpatient Followup', 'type': 'OTHER', 'description': 'Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) intervention patients will receive either cardiology or primary care referral (depending on risk level) and usual care patients will receive a primary care referral', 'armGroupLabels': ['Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) arm', 'Usual Care Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27517', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren Koehler', 'role': 'CONTACT'}], 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'centralContacts': [{'name': 'Lauren Koehler', 'role': 'CONTACT', 'email': 'lekoehle@wakehealth.edu', 'phone': '336-716-4646'}, {'name': 'Nick Ashburn', 'role': 'CONTACT', 'email': 'n.ashburn@wakehealth.edu'}], 'overallOfficials': [{'name': 'Nick Ashburn', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'n.ashburn@wakehealth.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}