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

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06713239 (PARAMOUNT) ist eine interventionsstudie zur Untersuchung von Koronararterienerkrankung und hat den Status offene rekrutierung. Die Studie startete am 18. Dezember 2024 und soll 1.000 Teilnehmer aufnehmen. Durchgeführt von Cleerly, Inc. ist der Abschluss für 1. Dezember 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 29. Oktober 2025 aktualisiert.
Kurzbeschreibung
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.
Offizieller Titel

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

Erkrankungen
Koronararterienerkrankung
Weitere Studien-IDs
  • PARAMOUNT
  • Pro00082528
NCT-Nummer
NCT06713239
Studienbeginn (tatsächlich)
2024-12-18
Zuletzt aktualisiert
2025-10-29
Studienende (vorauss.)
2025-12
Geplante Rekrutierung
1.000
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Diagnostisch
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellCoronary Plaque-Based Care
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.
Cleerly Labs and Cleerly ISCHEMIA
Participants in the coronary plaque-based care arm will have CCTA at baseline. CCTA images will be redacted and uploaded to Cleerly, interpreted using Cleerly Labs and Cleerly ISCHEMIA, and archived.
Keine InterventionUsual Care
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.
Nicht zutreffend
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
The primary endpoint is composed of multuple elements, which are to be compared between Coronary Plaque-Based care and the usual care arm, in a hierarchical fashion, using the win ratio approach: 1\. Improved diagnostic certainty of CAD
Through study completion- an average of 1 year
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
The primary endpoint is composed of multuple elements, which are to be compared between Coronary Plaque-Based care and the usual care arm, in a hierarchical fashion, using the win ratio approach: 2\. Reduction in LDL
Through study completion- an average of 1 year
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
The primary endpoint is composed of multuple elements, which are to be compared between Coronary Plaque-Based care and the usual care arm, in a hierarchical fashion, using the win ratio approach: 3\. Freedom from ICA without a finding of obstructive CAD
Through study completion- an average of 1 year
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
The primary endpoint is composed of multuple elements, which are to be compared between Coronary Plaque-Based care and the usual care arm, in a hierarchical fashion, using the win ratio approach: 4\. Freedom from PCI without finding of clinically significant stenosis
Through study completion- an average of 1 year
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
The secondary objective of the study is to determine whether a management strategy improves patients' experience of chest pain, quality of life, and adherence to medication.
The secondary endpoints assess angina symptoms, medication adherence, and quality of life. 1\. Change in angina symptoms assessed using the Seattle Angina Questionnaire.
Through study completion- an average of 1 year
The secondary objective of the study is to determine whether a management strategy improves patients' experience of chest pain, quality of life, and adherence to medication.
The secondary endpoints assess angina symptoms, medication adherence, and quality of life. 2\. Medication adherence assessed using the Voils DOSE-Nonadherence measure (Blalock, et al. 2019).
Through study completion- an average of 1 year
The secondary objective of the study is to determine whether a management strategy improves patients' experience of chest pain, quality of life, and adherence to medication.
The secondary endpoints assess angina symptoms, medication adherence, and quality of life. 3\. Quality of life assessed using the 20-item Short Form Survey (SF-20).
Through study completion- an average of 1 year
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • > 18 years
  • Symptomatic patients with suspicion of CAD, including those referred for elective, non-urgent diagnostic testing (e.g. stress test)

  • LDL < 100 mg/dL
  • Currently or previously treated beyond primary prevention guidelines
  • Suspected acute coronary syndrome or otherwise unstable clinical status
  • Planned cardiovascular procedure (e.g. coronary angiography, cardiac surgery, non-coronary vascular procedure)
  • Noninvasive or invasive CV testing for CAD within 1 year (e.g. invasive coronary angiography (ICA), coronary CT angiography (CCTA) including calcium scoring)
  • Known history of obstructive CAD (prior myocardial infarction, CABG or PCI, stenosis ≥50%)
  • Known EF ≤40% or other moderate to severe valvular or congenital cardiac disease
  • Contraindications to CCTA
Cleerly, Inc. logoCleerly, Inc.
Zentrale Studienkontakte
Kontakt: Ryann Sardinia, 7207398191, [email protected]
Kontakt: Vidhya Kumar, 7207398191, [email protected]
21 Studienstandorte in 1 Ländern

Alabama

Cardiology Associates of Mobile, Mobile, Alabama, 36608, United States
Jason Cole, MD, Kontakt
Offene Rekrutierung

California

Valiance Clinical Research- Huntington Park, Huntington Park, California, 90255, United States
Amir Rafie, MD, Kontakt
Offene Rekrutierung
Cardiovascular Institute of San Diego, San Diego, California, 91911, United States
Milind Parikh, MD, Kontakt
Offene Rekrutierung
Valiance Clinical Research- Tarzana, Tarzana, California, 91356, United States
Aamer Jamali, MD, Kontakt
Offene Rekrutierung
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, 90502, United States
Suvasini Lakshmanan, MD, Kontakt
Offene Rekrutierung

Colorado

Intermountain Health Saint Joseph Hospital, Broomfield, Colorado, 80021, United States
Christopher Angus, MD, Kontakt
Offene Rekrutierung

Florida

Tampa Cardiovascular Interventions and Research, Tampa, Florida, 33614, United States
Saihari Sadanandan, MD, Kontakt
Offene Rekrutierung
Flourish Research, Winter Park, Florida, 32789, United States
Monica Aggarwal, MD, Kontakt
Offene Rekrutierung

Illinois

Endeavor Health Clinical Operations, Evanston, Illinois, 60201, United States
Amit Pursnani, MD, Kontakt
Offene Rekrutierung

Iowa

MercyOne Des Moines Medical Center, West Des Moines, Iowa, 50266, United States
Enrico Martin, MD, Kontakt
Offene Rekrutierung

Kentucky

Saint Elizabeth Medical Center, Edgewood, Kentucky, 41017, United States
Travis Huffman, DO, Kontakt
Offene Rekrutierung

Louisiana

Tulane University, New Orleans, Louisiana, 70112, United States
Robert Hendel, MD, Kontakt
Offene Rekrutierung

Maryland

Flourish- Bowie, Bowie, Maryland, 20715, United States
Sara Collins, MD, Kontakt
Offene Rekrutierung

Missouri

St. Louis Heart and Vascular, Bridgeton, Missouri, 63044, United States
Gil Vardi, MD, Kontakt
Offene Rekrutierung

New Jersey

Advanced Heart and Vascular Institute of Hunterdon, Flemington, New Jersey, 08822, United States
Andrey Espinoza, MD, Kontakt
Offene Rekrutierung

New York

Capital Cardiology Associates, Albany, New York, 12211, United States
Augustin DeLago, MD, Kontakt
Offene Rekrutierung

Ohio

University of Cincinnatti, Cincinnati, Ohio, 45221, United States
Donald Wayne, MD, Kontakt
Offene Rekrutierung

Oklahoma

Oklahoma Cardiovascular Research Group, Oklahoma City, Oklahoma, 73120, United States
Mazen Abu-Fadel, MD, Kontakt
Offene Rekrutierung

Tennessee

The University of Tennessee Medical Center, Knoxville, Tennessee, 37920, United States
Kashif Shaikh, MD, Kontakt
Offene Rekrutierung

Texas

Medical City Fort Worth Hospital, Fort Worth, Texas, 76104, United States
Giri Mundluru, MD, Kontakt
Offene Rekrutierung

Virginia

Chippenham and Johnston Willis Hospitals, Richmond, Virginia, 23225, United States
Nayef Abouzaki, MD, Kontakt
Offene Rekrutierung