1000 Participants Needed

Personalized Therapy Management for Coronary Artery Disease

(PARAMOUNT Trial)

Recruiting at 11 trial locations
RS
VK
Overseen ByVidhya Kumar
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cleerly, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Cleerly Labs and Cleerly ISCHEMIA for coronary artery disease?

Research on personalized medicine in cardiovascular disease suggests that tailoring treatments based on individual characteristics, such as genetic or demographic factors, can improve outcomes. This approach has been used in other cardiovascular conditions, indicating potential benefits for personalized therapy management in coronary artery disease.12345

Is there any safety data available for personalized therapy management for coronary artery disease?

The research articles do not provide specific safety data for the treatment under the names Cleerly Labs or Cleerly ISCHEMIA, but they discuss the importance of personalized medicine in identifying patients who may experience adverse reactions and tailoring therapy accordingly.15678

How is the treatment Cleerly Labs and Cleerly ISCHEMIA unique for coronary artery disease?

This treatment is unique because it uses personalized therapy management, which involves tailoring the treatment to the individual patient's genetic and proteomic profile. This approach aims to identify patients who are most likely to benefit from the treatment and those who might experience adverse reactions, making it more precise compared to standard treatments.145910

What is the purpose of this trial?

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.

Research Team

TV

Todd Villines, MD

Principal Investigator

University of Virginia

MF

Maros Ferencik, MD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

This trial is for people with symptoms suggesting they might have coronary artery disease (CAD). They should be candidates for a CT scan to check their heart arteries. The study excludes those who can't undergo CT scans, are pregnant, or have other serious health issues that could interfere with the trial.

Inclusion Criteria

I have symptoms that may suggest heart disease and might need a stress test.
I am over 18 years old.

Exclusion Criteria

LDL levels below 100 mg/dL
Currently or previously treated beyond primary prevention guidelines
I cannot undergo CCTA due to health reasons.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized management based on coronary plaque assessment or usual care

6 months
Baseline and 180 days assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • Cleerly Labs and Cleerly ISCHEMIA
Trial Overview The PARAMOUNT trial is testing if using AI software to analyze CT images of heart arteries can better manage CAD compared to usual care based on AHA/ACC guidelines. It looks at diagnosis certainty, risk factor control, and efficient use of invasive procedures.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Coronary Plaque-Based CareExperimental Treatment1 Intervention
Patients randomized to the Coronary Plaque-Based Care arm will undergo CCTA with AI-enabled quantitative assessment of the morphology and composition of coronary atherosclerotic plaque and will receive medical and interventional management informed by CCTA findings and per discretion of the treating physician. All patients will receive a standardized assessment of clinical and risk factor status at baseline and 180 days.
Group II: Usual CareActive Control1 Intervention
Patients randomized to the Usual Care arm will be referred to their usual care providers for standard of care management post stress test findings, possibly including coronary angiography and/or revascularization per the treating provider's recommendation. All patients will receive a standardized assessment of clinical and risk factor status at baseline and 180 days.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cleerly, Inc.

Lead Sponsor

Trials
4
Recruited
45,200+

Findings from Research

Personalized medicine aims to tailor treatments based on individual patient characteristics, including genetic and demographic factors, to improve efficacy and reduce adverse reactions, particularly in cardiovascular disease.
The development of biomarker-based approaches in cardiovascular medicine has been challenging due to the complexity of diseases like heart failure, but better disease classification and understanding of individual variations could lead to more effective targeted therapies.
Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective.Blaus, A., Madabushi, R., Pacanowski, M., et al.[2019]
In a cohort study of 34 patients with coronary artery disease and refractory chest pain, 71% were found to have identifiable causes for their symptoms, primarily gastroesophageal reflux disease (GERD), which was treatable with high-dose acid suppression therapy.
After 8 weeks of treatment, 67% of patients with acid reflux-related chest pain experienced significant improvement or resolution of their symptoms, highlighting the importance of investigating non-cardiac causes of chest pain in these patients.
The contribution of gastroesophageal reflux to chest pain in patients with coronary artery disease.Singh, S., Richter, JE., Hewson, EG., et al.[2019]
Personalized medicine uses an individual's unique biological information to enhance treatment for vascular diseases, but implementing this approach in clinical practice is still challenging.
Recent advancements in pharmacogenomics and vascular biology allow for better customization of four key drug classes in vascular medicine, with ongoing clinical trials needed to compare these personalized strategies against standard treatments.
Personalized vascular medicine: individualizing drug therapy.Degoma, EM., Rivera, G., Lilly, SM., et al.[2022]

References

Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective. [2019]
The contribution of gastroesophageal reflux to chest pain in patients with coronary artery disease. [2019]
Personalized vascular medicine: individualizing drug therapy. [2022]
Precision Phenomapping of Acute Coronary Syndromes to Improve Patient Outcomes. [2021]
Genotype-guided antiplatelet therapy compared with standard therapy for patients with acute coronary syndromes or undergoing percutaneous coronary intervention: A systematic review and meta-analysis. [2021]
The Genetics of Ischemic Heart Disease: From Current Knowledge to Clinical Implications. [2021]
Rationale and design of the TAILOR-PCI digital study: Transitioning a randomized controlled trial to a digital registry. [2023]
Disconnect Between Genes Associated With Ischemic Heart Disease and Targets of Ischemic Heart Disease Treatments. [2022]
[The evolution of medical research: from trials to tailored therapy]. [2011]
Personalized Management of Cardiovascular Disorders. [2018]
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