Personalized Therapy Management for Coronary Artery Disease

(PARAMOUNT Trial)

Recruiting at 22 trial locations

Overseen By Vidhya Kumar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cleerly, Inc.

Disqualifiers: Low LDL, Acute coronary syndrome, Prior CAD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 180

Duration: 6 months

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a personalized management strategy can better diagnose and treat coronary artery disease (CAD) using advanced imaging technology. AI-enabled software (Cleerly Labs and Cleerly ISCHEMIA) analyzes plaques in the coronary arteries through a CT scan, aiming to improve diagnosis and treatment compared to usual care. The study includes two groups: one receiving personalized care based on plaque analysis and the other receiving standard treatment. Ideal participants are those experiencing symptoms suggesting CAD and who have been recommended for non-urgent diagnostic testing, such as a stress test. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future CAD diagnosis and treatment.

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 prior data suggests that this personalized management strategy is safe for coronary artery disease patients?

Research shows that Cleerly Labs and Cleerly ISCHEMIA use artificial intelligence to analyze heart scans. These tools help doctors assess arterial plaque, crucial for diagnosing heart problems. The FDA has reviewed Cleerly ISCHEMIA, confirming it meets safety standards for healthcare use.

While specific data on side effects or issues from using these tools is not available, the FDA review suggests they are quite safe. Being non-invasive, they do not involve surgery or entering the body, which generally reduces the risk of side effects.

In summary, Cleerly Labs and Cleerly ISCHEMIA are designed to be safe and assist doctors in making better heart care decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a personalized approach to managing coronary artery disease using AI-driven technology. Unlike traditional treatments that often rely on stress tests and standard care management, this approach uses AI-enabled quantitative assessment through Coronary Computed Tomography Angiography (CCTA) to analyze the morphology and composition of coronary plaque. This allows for a more tailored medical and interventional management plan, potentially leading to more precise and effective treatment strategies. By integrating advanced imaging and AI, the trial aims to enhance decision-making and improve patient outcomes in a way that current standard treatments may not.

What evidence suggests that this trial's treatments could be effective for coronary artery disease?

Research has shown that Cleerly's AI technology effectively diagnoses and assesses coronary artery disease (CAD). The AI scans accurately measure plaque in the arteries, aiding in understanding the risk of heart problems. Studies indicate that this technology can predict serious heart issues in symptomatic patients. In this trial, participants in the Coronary Plaque-Based Care arm will undergo CCTA with Cleerly's AI-enabled quantitative assessment to manage CAD risk. Cleerly's tool examines heart images to identify artery blockages, providing a non-invasive method for managing CAD risk. Overall, these findings suggest that using Cleerly's AI in CAD management may enhance diagnosis and treatment decisions. ^{2 6 7 8 9}

Who Is on the Research Team?

Todd Villines, MD

Principal Investigator

University of Virginia

Maros Ferencik, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Coronary Plaque-Based Care Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

Cleerly, Inc.

Lead Sponsor

Trials

4

Recruited

45,200+

Published Research Related to This Trial

Recent advancements in genomics and proteomics are transforming cardiac disease research and therapy, enabling a better understanding of heart conditions like ischemia and heart failure.

The application of genetic and proteomic tests in clinical settings shows promise for developing personalized medicine approaches, tailoring treatments based on individual genetic expression and protein activation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The evolution of medical research: from trials to tailored therapy]. Pasini, E., Pirelli, S., Di Lenarda, A., et al.[2011]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The contribution of gastroesophageal reflux to chest pain in patients with coronary artery disease. Singh, S., Richter, JE., Hewson, EG., et al.[2019]

In a meta-analysis of 4859 patients from 7 randomized clinical trials, genotype-guided treatment with P2Y12 inhibitors significantly reduced the risk of high on-treatment platelet reactivity (HTPR), myocardial infarction (MI), and stent thrombosis (ST) compared to standard treatment.

The study found no significant differences in major bleeding events or mortality between the genotype-guided and standard treatment groups, suggesting that personalized treatment is both effective and safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Wang, X., Wang, S., Yang, J., et al.[2021]

Acute coronary syndromes (ACS) are a major cause of death worldwide, and precision medicine is being used to tailor treatments based on individual patient characteristics, improving outcomes.

Current precision treatments for ACS include immediate coronary revascularization for ST-segment elevation, early coronary angiography for elevated troponins, and personalized antithrombotic therapy based on bleeding risk, highlighting the need for more detailed analyses of patient data to enhance treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Phenomapping of Acute Coronary Syndromes to Improve Patient Outcomes. Andreotti, F., Iervolino, A., Navarese, EP., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Personalized management of cardiovascular disorders (CVD) utilizes various 'omics' technologies and molecular diagnostics to tailor treatments based on individual patient profiles, improving the effectiveness of interventions.

A systems biology approach helps in risk stratification and treatment modeling, allowing for individualized recommendations that consider genetic and epigenetic factors, ultimately enhancing patient care in conditions like heart failure and hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Management of Cardiovascular Disorders. Jain, KK.[2018]

Only 8 out of 236 genes targeted by current ischemic heart disease (IHD) treatments are also genetically validated, indicating a significant gap between genetic research and treatment development.

There are opportunities to improve IHD treatment by aligning them more closely with genetically validated targets, which could involve repurposing existing interventions and exploring additional genetic targets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disconnect Between Genes Associated With Ischemic Heart Disease and Targets of Ischemic Heart Disease Treatments. Schooling, CM., Huang, JV., Zhao, JV., et al.[2022]

Recent advancements in understanding the genetics of ischemic heart disease have led to the identification of new therapeutic targets and improved risk prediction methods, which are crucial for effective prevention and treatment.

The integration of genetic insights into clinical practice allows for better assessment of biomarkers related to the disease and helps identify which patients are likely to respond to specific medications, enhancing personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Genetics of Ischemic Heart Disease: From Current Knowledge to Clinical Implications. Elosua, R., Sayols-Baixeras, S.[2021]

The TAILOR-PCI Digital Study is exploring the feasibility of using digital technology to extend follow-up for patients in a large cardiovascular trial, potentially improving the monitoring of ischemic outcomes after PCI.

By utilizing a digital platform for data collection and patient engagement, the study aims to assess the effectiveness of transitioning from traditional follow-up methods to a digital registry, which could enhance patient tracking and data accuracy, especially in the context of challenges posed by COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of the TAILOR-PCI digital study: Transitioning a randomized controlled trial to a digital registry. Pereira, NL., Avram, R., So, DY., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized vascular medicine: individualizing drug therapy. Degoma, EM., Rivera, G., Lilly, SM., et al.[2022]

Citations

1. cleerlyhealth.com cleerlyhealth.com/press/cleerly-ischemia-diagnostic-accuracy-prognostic-utility

Cleerly® ISCHEMIA™ Demonstrates Diagnostic Accuracy ... Study describes the validation of Cleerly's AI-guided quantitative CCTA (AI-QCT) ISCHEMIA technology for diagnostic accuracy and prognostic utility.

2. cleerlyhealth.com cleerlyhealth.com/ischemia-reinvented

Cleerly Non-Invasive Ischemia Analysis Cleerly ISCHEMIA predicts the likelihood of ischemia using AI-enabled analysis of coronary CTA scans, including measure of coronary plaque.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11057943/

Prognostic value of a novel artificial intelligence-based ... AI-QCT ischaemia may be useful to improve risk stratification, especially amongst patients with no/non-obstructive CAD on coronary CTA.

4. cleerlyhealth.com cleerlyhealth.com/press/research-on-ai-enabled-quantitative-ct-coronary-assessment

Cleerly Presents Late-Breaking Research on AI-Enabled ... A non-invasive, comprehensive AI-based analysis of cardiac computed tomography (CT) can predict serious heart-related events in patients who show symptoms of ...

5. cleerlyhealth.com cleerlyhealth.com/patient-education

Cleerly Plaque Analysis for Heart Disease Detection Cleerly is a tool that interprets images of the heart and detects plaque in the arteries. It uses advanced machine learning to find indicators of blockages and ...

6. cleerlyhealth.com cleerlyhealth.com/

Cleerly: Personalized Analysis and Treatment of Heart Disease Cleerly is a comprehensive, AI-driven platform that quantifies and assesses coronary artery disease (CAD) to deliver clinically actionable insights through a ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K231335.pdf

September 8, 2023 Cleerly, Inc John Smith Partner Hogan ... Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, indicated as a diagnostic aid for patients ...

8. cleerlyhealth.com cleerlyhealth.com/blog/clinical-research-acc-2023

Q&A with Dr. James Earls: New Clinical Research Shared ... Cleerly talks to Dr. James Earls about new clinical research present at ACC/WCC 2023; an essential conference for cardiology professionals.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06713239?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Cleerly,%20Inc.%22))&rank=1

Study Details | NCT06713239 | A Randomized ... A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. Usual Care for Symptomatic Patients With Suspicion of CAD ( ...