Ignite Creation Date:
2024-07-17 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488105
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Initiating Preventive Care for Hyperlipidemia in the Emergency Department The EMERALD Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMERALD RCT
Brief Summary:
Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders EMERALD is a protocolized intervention based on American College of CardiologyAmerican 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
Detailed Description:
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
We 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 11 to EMERALD or usual care which will provide 90 power with a two-sided alpha of 005 to demonstrate a 10 difference in percent change in LDL-C at 30-days between arms
We 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 11 to EMERALD or usual care which will provide 90 power with a two-sided alpha of 005 to demonstrate a 10 difference in percent change in LDL-C at 30-days between arms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23HL169929-01A1 | NIH | None | None |