Trial Outcomes & Findings for EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) (NCT NCT05742841)

NCT ID: NCT05742841

Last Updated: 2024-05-21

Results Overview

A lipid panel is a common blood test that healthcare providers use to monitor and screen for risk of cardiovascular disease. The panel includes three measurements of your cholesterol levels and a measurement of your triglycerides.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

22 participants

Primary outcome timeframe

Baseline and Day 30

Results posted on

2024-05-21

Participant Flow

Participant milestones

Participant milestones
Measure
EMERALD Protocol
1\) ordering a lipid panel during the index ED encounter and 30-days (+/- 5 business days) after ED discharge, 2) completion of the Pooled Cohort Equations by the patient's ED provider at the index visit, and 3) starting medical therapy (moderate- or high-intensity statin/ rosuvastatin) in the ED moderate- or high-intensity statin/ rosuvastatin: moderate- or high-intensity statin (either rosuvastatin 10mg daily or rosuvastatin 40 mg daily)
Overall Study
STARTED
22
Overall Study
COMPLETED
20
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
EMERALD Protocol
1\) ordering a lipid panel during the index ED encounter and 30-days (+/- 5 business days) after ED discharge, 2) completion of the Pooled Cohort Equations by the patient's ED provider at the index visit, and 3) starting medical therapy (moderate- or high-intensity statin/ rosuvastatin) in the ED moderate- or high-intensity statin/ rosuvastatin: moderate- or high-intensity statin (either rosuvastatin 10mg daily or rosuvastatin 40 mg daily)
Overall Study
Withdrawal by Subject
1
Overall Study
Lost to Follow-up
1

Baseline Characteristics

EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
EMERALD Protocol
n=20 Participants
1\) ordering a lipid panel during the index ED encounter and 30-days (+/- 5 business days) after ED discharge, 2) completion of the Pooled Cohort Equations by the patient's ED provider at the index visit, and 3) starting medical therapy (moderate- or high-intensity statin/ rosuvastatin) in the ED moderate- or high-intensity statin/ rosuvastatin: moderate- or high-intensity statin (either rosuvastatin 10mg daily or rosuvastatin 40 mg daily)
Age, Categorical
<=18 years
0 Participants
n=39 Participants
Age, Categorical
Between 18 and 65 years
19 Participants
n=39 Participants
Age, Categorical
>=65 years
1 Participants
n=39 Participants
Age, Continuous
53.5 years
n=39 Participants
Sex: Female, Male
Female
13 Participants
n=39 Participants
Sex: Female, Male
Male
7 Participants
n=39 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=39 Participants
Race (NIH/OMB)
Asian
0 Participants
n=39 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=39 Participants
Race (NIH/OMB)
Black or African American
14 Participants
n=39 Participants
Race (NIH/OMB)
White
6 Participants
n=39 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=39 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=39 Participants
Region of Enrollment
United States
20 Participants
n=39 Participants

PRIMARY outcome

Timeframe: Baseline and Day 30

Population: only participants that qualified for study drug were analyzed - 16, not all 20 Participants

A lipid panel is a common blood test that healthcare providers use to monitor and screen for risk of cardiovascular disease. The panel includes three measurements of your cholesterol levels and a measurement of your triglycerides.

Outcome measures

Outcome measures
Measure
EMERALD Protocol
n=16 Participants
1\) ordering a lipid panel during the index ED encounter and 30-days (+/- 5 business days) after ED discharge, 2) completion of the Pooled Cohort Equations by the patient's ED provider at the index visit, and 3) starting medical therapy (moderate- or high-intensity statin/ rosuvastatin) in the ED moderate- or high-intensity statin/ rosuvastatin: moderate- or high-intensity statin (either rosuvastatin 10mg daily or rosuvastatin 40 mg daily)
Low-density Lipoprotein Cholesterol (LDL-C) Levels at Baseline and Day 30
Baseline LDL-C
110 mg/dL
Interval 89.5 to 144.5
Low-density Lipoprotein Cholesterol (LDL-C) Levels at Baseline and Day 30
Day 30 LDL-C
84.0 mg/dL
Interval 60.0 to 111.0

Adverse Events

EMERALD Protocol

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nick Ashburn

Wake Forest School of Medicine

Phone: 336-716-4646

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place