Personalized Therapy Management for Coronary Artery Disease
(PARAMOUNT Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Cleerly, Inc.
Disqualifiers: Low LDL, Acute coronary syndrome, Prior CAD, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
15678How 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.
145910Eligibility 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.
+5 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Cardiology of Mobile, Inc.Mobile, AL
Cardiology Associates of MobileMobile, AL
Chippenham and Johnston Willis HospitalsRichmond, VA
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Who Is Running the Clinical Trial?
Cleerly, Inc.Lead Sponsor
References
Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective. [2019]Over the past decade, personalized medicine has received considerable attention from researchers, drug developers, and regulatory agencies. Personalized medicine includes identifying patients most likely to benefit and those most likely to experience adverse reactions in response to a drug, and tailoring therapy based on pharmacokinetics or pharmacodynamic response, as well. Perhaps most exciting is finding ways to identify likely responders through genetic, proteomic, or other tests, so that only likely responders will be treated. However, less precise methods such as identifying historical, demographic, or other indicators of increased or reduced responsiveness are also important aspects of personalized medicine. The cardiovascular field has not used many genetic or proteomic markers, but has regularly used prognostic variables to identify likely responders. The development of biomarker-based approaches to personalized medicine in cardiovascular disease has been challenging, in part, because most cardiovascular therapies treat acquired syndromes, such as acute coronary syndrome and heart failure, which develop over many decades and represent the end result of several pathophysiological mechanisms. More precise disease classification and greater understanding of individual variations in disease pathology could drive the development of targeted therapeutics. Success in designing clinical trials for personalized medicine will require the selection of patient populations with attributes that can be targeted or that predict outcome, and the use of appropriate enrichment strategies once such attributes are identified. Here, we describe examples of personalized medicine in cardiovascular disease, discuss its impact on clinical trial design, and provide insight into the future of personalized cardiovascular medicine from a regulatory perspective.
The contribution of gastroesophageal reflux to chest pain in patients with coronary artery disease. [2019]To describe the effectiveness of investigating and treating the cause of refractory chest pain in patients with coronary artery disease who are receiving optimal antianginal therapy.
Personalized vascular medicine: individualizing drug therapy. [2022]Personalized medicine refers to the application of an individual's biological fingerprint - the comprehensive dataset of unique biological information - to optimize medical care. While the principle itself is straightforward, its implementation remains challenging. Advances in pharmacogenomics as well as functional assays of vascular biology now permit improved characterization of an individual's response to medical therapy for vascular disease. This review describes novel strategies designed to permit tailoring of four major pharmacotherapeutic drug classes within vascular medicine: antiplatelet therapy, antihypertensive therapy, lipid-lowering therapy, and antithrombotic therapy. Translation to routine clinical practice awaits the results of ongoing randomized clinical trials comparing personalized approaches with standard of care management.
Precision Phenomapping of Acute Coronary Syndromes to Improve Patient Outcomes. [2021]Acute coronary syndromes (ACS) are a global leading cause of death. These syndromes show heterogeneity in presentation, mechanisms, outcomes and responses to treatment. Precision medicine aims to identify and synthesize unique features in individuals, translating the acquired data into improved personalised interventions. Current precision treatments of ACS include immediate coronary revascularisation driven by ECG ST-segment elevation, early coronary angiography based on elevated blood cardiac troponins in patients without ST-segment elevation, and duration of intensified antithrombotic therapy according to bleeding risk scores. Phenotypically stratified analyses of multi-omic datasets are urgently needed to further refine and couple the diagnosis and treatment of these potentially life-threatening conditions. We provide definitions, examples and possible ways to advance precision treatments of ACS.
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]To determine, in patients with acute coronary syndromes (ACS) or undergoing percutaneous coronary intervention (PCI), the effectiveness and safety between personalized P2Y12 inhibitors treatment based on genotypes and standard treatment.
The Genetics of Ischemic Heart Disease: From Current Knowledge to Clinical Implications. [2021]Ischemic heart disease continues to cause high morbidity and mortality. Its prevalence is expected to increase due to population aging, and its prevention is a major goal of health policies. The risk of developing ischemic heart disease is related to a complex interplay between genetic, environmental, and lifestyle factors. In the last decade, considerable progress has been made in knowledge of the genetic architecture of this disease. This narrative review provides an overview of current knowledge of the genetics of ischemic heart disease and of its translation to clinical practice: identification of new therapeutic targets, assessment of the causal relationship between biomarkers and disease, improved risk prediction, and identification of responders and nonresponders to specific drugs (pharmacogenomics).
Rationale and design of the TAILOR-PCI digital study: Transitioning a randomized controlled trial to a digital registry. [2023]Label="BACKGROUND">Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI) is the largest cardiovascular genotype-based randomized pragmatic trial (NCT#01742117) to evaluate the role of genotype-guided selection of oral P2Y12 inhibitor therapy in improving ischemic outcomes after PCI. The trial has been extended from the original 12- to 24-month follow-up, using study coordinator-initiated telephone visits. TAILOR-PCI Digital Study tests the feasibility of extending the trial follow-up in a subset of patients for up to 24 months using state-of-the-art digital solutions. The rationale, design, and approach of extended digital study of patients recruited into a large, international, multi-center clinical trial has not been previously described.
Disconnect Between Genes Associated With Ischemic Heart Disease and Targets of Ischemic Heart Disease Treatments. [2022]Development of pharmacological treatments to mitigate ischemic heart disease (IHD) has encompassed disappointing results and expensive failures, which has discouraged investment in new approaches to prevention and control. New treatments are most likely to be successful if they act on genetically validated targets. We assessed whether existing pharmacological treatments for IHD reduction are acting on genetically validated targets and whether all such targets for IHD are currently being exploited.
[The evolution of medical research: from trials to tailored therapy]. [2011]Medical research and consequently therapy are undergoing dramatic transformation. New science on genomics and proteomics has given us important information on the pathophysiology of many cardiac diseases and personalized responses to specific patient-oriented therapies. The application of cellular genetic and proteome tests is a promising field of research and their clinical use can allow us to both: 1) understand the causes and evolution of heart diseases such as ischemia and heart failure better, 2) lead to personalized medicine. This article focuses on the basic intracellular-related evidence and the unsolved problems and complexity of intracellular signaling that still need to be studied to understand personalized therapies better. In addition, we provide preliminary clinical data that support the potentiality of this new but fundamental approach of curing patients according to their genetic expression and/or protein activation that influence personalized development and the management of cardiovascular diseases.
Personalized Management of Cardiovascular Disorders. [2018]Personalized management of cardiovascular disorders (CVD), also referred to as personalized or precision cardiology in accordance with general principles of personalized medicine, is selection of the best treatment for an individual patient. It involves the integration of various "omics" technologies such as genomics and proteomics as well as other new technologies such as nanobiotechnology. Molecular diagnostics and biomarkers are important for linking diagnosis with therapy and monitoring therapy. Because CVD involve perturbations of large complex biological networks, a systems biology approach to CVD risk stratification may be used for improving risk-estimating algorithms, and modeling of personalized benefit of treatment may be helpful for guiding the choice of intervention. Bioinformatics tools are helpful in analyzing and integrating large amounts of data from various sources. Personalized therapy is considered during drug development, including methods of targeted drug delivery and clinical trials. Individualized recommendations consider multiple factors - genetic as well as epigenetic - for patients' risk of heart disease. Examples of personalized treatment are those of chronic myocardial ischemia, heart failure, and hypertension. Similar approaches can be used for the management of atrial fibrillation and hypercholesterolemia, as well as the use of anticoagulants. Personalized management includes pharmacotherapy, surgery, lifestyle modifications, and combinations thereof. Further progress in understanding the pathomechanism of complex cardiovascular diseases and identification of causative factors at the individual patient level will provide opportunities for the development of personalized cardiology. Application of principles of personalized medicine will improve the care of the patients with CVD.