RECRUITING

A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. Usual Care for Symptomatic Patients With Suspicion of CAD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

PARAMOUNT is a prospective randomized open-label trial testing the hypothesis that a personalized management strategy in symptomatic patients with suspicion of coronary artery disease (CAD), using a CT-based coronary atherosclerotic plaque assessment by AI-enabled quantitative software improves: certainty for diagnosis of CAD, control of CAD risk factors and efficiency of ICA referral with appropriate PCI compared to the usual care strategy based on current AHA/ACC guidelines for care of symptomatic patients with suspicion of CAD.

Official Title

A Randomized Comparison of Personalized Management for Medical and Interventional Therapy Based On Coronary Atherosclerotic Plaque Versus Usual Care for Symptomatic Patients With Suspicion of CAD

Quick Facts

Study Start:2024-12-18
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06713239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \> 18 years
  2. * Symptomatic patients with suspicion of CAD, including those referred for elective, non-urgent diagnostic testing (e.g. stress test)
  1. * LDL \< 100 mg/dL
  2. * Currently or previously treated beyond primary prevention guidelines
  3. * Suspected acute coronary syndrome or otherwise unstable clinical status
  4. * Planned cardiovascular procedure (e.g. coronary angiography, cardiac surgery, non-coronary vascular procedure)
  5. * Noninvasive or invasive CV testing for CAD within 1 year (e.g. invasive coronary angiography (ICA), coronary CT angiography (CCTA) including calcium scoring)
  6. * Known history of obstructive CAD (prior myocardial infarction, CABG or PCI, stenosis ≥50%)
  7. * Known EF ≤40% or other moderate to severe valvular or congenital cardiac disease
  8. * Contraindications to CCTA

Contacts and Locations

Study Contact

Ryann Sardinia
CONTACT
7205931599
ryann.sardinia@cleerlyhealth.com
Vidhya Kumar
CONTACT
7205931599
vidhya.kumar@cleerlyhealth.com

Principal Investigator

Todd Villines, MD
PRINCIPAL_INVESTIGATOR
University of Virginia
Maros Ferencik, MD
PRINCIPAL_INVESTIGATOR
Oregon Health and Science University

Study Locations (Sites)

Cardiology Associates of Mobile
Mobile, Alabama, 36608
United States

Collaborators and Investigators

Sponsor: Cleerly, Inc.

  • Todd Villines, MD, PRINCIPAL_INVESTIGATOR, University of Virginia
  • Maros Ferencik, MD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-18
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-12-18
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Coronary Artery Disease