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Идёт набор NCT06488105

Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial

Фаза II С лечением Lipid Disorder Hypercholesterolemia Cardiovascular Diseases Atherosclerosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Statin (rosuvastatin 10 or 40 mg daily, depending on risk), Healthy Lifestyle Counseling, Outpatient Followup.
Кому может быть актуально
Состояния в реестре: Lipid Disorder, Hypercholesterolemia, Cardiovascular Diseases, Atherosclerosis. Базовые параметры: 40 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Initiating Preventive Care for Hyperlipidemia in the Emergency Department: The EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) Trial

Обзор

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.

Подробное описание

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 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.

Вмешательства

  • Препарат Statin (rosuvastatin 10 or 40 mg daily, depending on risk)
    moderate- or high-intensity statin (either rosuvastatin 10 mg daily or rosuvastatin 40 mg daily)
  • Поведенческое Healthy Lifestyle Counseling
    Healthy lifestyle counseling based off the American Heart Association's Life Essential 8 framework
  • Другое Outpatient Followup
    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

Первичные конечные точки

  • Percent change in low-density lipoprotein cholesterol (LDL-C) at 30 days [Срок оценки: Index ED encounter through 30 days (-3, +11 days)]
Вторичные конечные точки (6)
  • Percent change in LDL-C at 180 days. [Срок оценки: Index ED encounter through 180 days (+/- 15 days)]
  • Percent change in non high-density lipoprotein cholesterol (non-HDL-C) at 30 days [Срок оценки: Index ED encounter through 30 days (-3, +11 days)]
  • Percent change in non-HDL-C at 180 days [Срок оценки: Index ED encounter through 180 days (+/- 15 days)]
  • Proportion of patients with outpatient clinic follow-up at 30 days [Срок оценки: Index ED encounter through 30 days (-3, +8 days)]
  • Proportion of patients with statin prescription pick-up [Срок оценки: Index ED encounter through 10 days]
  • Qualitative barriers and facilators [Срок оценки: 30 days (+30 days) after the index ED encounter]

Критерии участия

Критерии включения

  • Evaluation for Acute Coronary Syndrome
  • Age 40-75 Years
  • 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk ≥7.5% or Known Diabetes or

Known ASCVD:

  • Myocardial Infarction
  • Unstable Angina
  • Percutaneous Coronary Intervention
  • Coronary Artery Bypass Graft
  • Stroke
  • Transient Ischemic Attack
  • Peripheral Artery Disease

Критерии исключения

  • ST-Segment Elevation Myocardial Infarction (STEMI) Activation
  • ST Depression >1 mm in Contiguous Leads
  • On a Lipid Lowering Agent (Statin, PCSK9 Inhibitor, Bempedoic Acid, Ezetimibe, Inclisiran, etc.)
  • Inability to Return for 30-day Follow-up
  • Unstable Vitals (Systolic blood pressure <90, HR >120 or <50, oxygen saturation <90%)
  • Statin Intolerance
  • Any Resulted High-Sensitivity Troponin I ≥100 ng/L
  • End-stage renal disease (ESRD) and/or glomerular filtration rate (GFR) <30 mL/min/1.73 m2
  • Liver Cirrhosis
  • Pregnancy
  • Anticipated Hospitalization
  • Life Expectancy <1 Year
  • Transfer from Another Hospital
  • Prisoner
  • Non-English Speaking

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Wake Forest University Health Sciences — Winston-Salem

Идентификаторы

NCT: NCT06488105 · IRB00104057 · 1K23HL169929-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗