Screening for Mild Heart Disease with Treatment Options

PRE-EMPT: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis

Recruiting Phase 3 Interventional Study
Coronary Artery Disease Risk Factors Multiple Coronary Artery Disease Progression Prevention & Control Premature Atherosclerosis
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
30 – 60
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
1,500 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for

This trial is looking for people at low risk of heart disease to check for early signs of cholesterol build-up in heart arteries. If selected, participants may take part in a two-year treatment study testing medications to help manage this condition.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am a woman aged 40-60 years or a man aged 30-50 years.
  • I can provide informed consent and follow study procedures.
  • I use a smartphone.
  • I use effective birth control if I could become pregnant.
  • I have a Coronary Artery Calcium score between 1 and 99.
  • I have a baseline CCTA result with a specific measure of plaque.

You may not be able to join if

  • I have been diagnosed with coronary artery disease or other heart diseases.
  • I currently have symptoms related to heart disease.
  • I have a 10-year heart disease risk of 5% or more.
  • I have diabetes or a high blood sugar level.
  • I have a high cholesterol level.
  • I have HIV.
  • I am pregnant, breastfeeding, or plan to become pregnant.
  • I have severe kidney problems.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. This clinical trial will test if screening and early treatment of mild heart disease works. PRE-EMPT will screen individuals at low 10-year risk of heart disease with heart disease risk factors to identify those who already have early cholesterol build up, also called "pla…
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: 1. Women aged 40-60 years; Men aged 30-50 years 2. Willing and able to provide informed consent and comply with study procedures 3. Smart phone user 4. Use of highly effective contraception by females with reproductive potential. 5. CAC score 1-99 in the screening study or entry…
Contacts

Rachel Olson, Project Manager

919-309-5544

rachel.e.olson@duke.edu

CONTACT