Personalized Therapy Management for Coronary Artery Disease

(PARAMOUNT Trial)

Recruiting at 13 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

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

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. ^{1 4 5 9 10}

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

Todd Villines, MD

Principal Investigator

University of Virginia

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.

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

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+

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.

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The contribution of gastroesophageal reflux to chest pain in patients with coronary artery disease. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Personalized vascular medicine: individualizing drug therapy. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Precision Phenomapping of Acute Coronary Syndromes to Improve Patient Outcomes. [2021]

5. United States 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. [2021]

6. Spain pubmed.ncbi.nlm.nih.gov

The Genetics of Ischemic Heart Disease: From Current Knowledge to Clinical Implications. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Rationale and design of the TAILOR-PCI digital study: Transitioning a randomized controlled trial to a digital registry. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Disconnect Between Genes Associated With Ischemic Heart Disease and Targets of Ischemic Heart Disease Treatments. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

[The evolution of medical research: from trials to tailored therapy]. [2011]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Personalized Management of Cardiovascular Disorders. [2018]