REWRITE-CAD Protocol: Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease (REWRITE-CAD)
Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease
REWRITE-CAD is a prospective, randomized, multi-center trial assessing the management of asymptomatic participants with a history of PCI or MI who will undergo a blinded CCTA and be randomly assigned to either the test arm in which participants receive the unblinded results of Heartflow AI-CPA or the usual care arm in which participants are blinded to the AI-CPA results.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The objective of the REWRITE-CAD trial is to assess changes in lipid lowering therapy over time in participants with a history of PCI or MI who undergo a blinded CCTA and are randomly assigned to either the test arm in which participants will undergo a blinded CCTA and receive the unblinded Heartflow AI-CPA results or the usual care arm in which participants will undergo a blinded CCTA with blinded AI-CPA results.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Whitney Huey
- Numéro de téléphone: 877-478-3569
- E-mail: whuey@heartflow.com
Sauvegarde des contacts de l'étude
- Nom: Zachary Sterner, Ph.D
- Numéro de téléphone: 877-478-3569
- E-mail: zsterner@heartflow.com
Lieux d'étude
-
-
North Carolina
-
Greensboro, North Carolina, États-Unis, 27401
- REWRITE-CAD Trial Site
-
Contact:
- Heartflow Investigator
- Numéro de téléphone: 877-478-3569
- E-mail: rewrite-cad@heartflow.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- History of PCI (1 year - 5 years prior to Day 0) and/or history of MI (Type I or II) (1 year - 5 years prior to Day 0)
- Patients who do not exhibit symptoms suggestive of CAD
- No other clinical CCTA subsequent to MI/PCI but prior to screening
- eGFR >45 mL/min per most recent measurement within 90 days
- Willingness to comply with all aspects of the protocol including research CCTAs, lab draws, medication adherence assessments, attending all study visits, and the ability to comply with prescribed medications
- For a female participant of childbearing potential (those who have not been surgically sterilized), a pregnancy test must be performed with negative results known within 7 days prior to randomization
- Ability to provide informed consent
- Visible plaque in non-stented region on CCTA as assessed by CCTA core lab
- Acceptable CCTA quality per Heartflow acceptance criteria
Exclusion Criteria:
Non-imaging based
-
Symptoms suggestive of CAD (e.g. stable angina or dyspnea on exertion)
-
On PCSK9i and/or inclisiran at baseline
-
Reduced left ventricular ejection fraction (LVEF) <35%, if known
-
Prior coronary artery bypass graft (CABG)
-
Prior stents in 2+ vessel territories
-
Life expectancy less than 2 years due to non-CV comorbidities
-
Enrolled in an investigational trial that involves a non-approved cardiac drug or device
-
Previously evaluated with and/or in a trial which includes AI-CPA
-
Any condition that might interfere with trial procedures or follow up visits
-
LDL-C <70 mg/dL at baseline lab draw
-
Active chemotherapy and/or radiation
Imaging Based (all to be assessed by CCTA core lab)
-
Left Main (LM) ≥50% stenosis on baseline CCTA
-
Proximal LAD FFRct <0.75
-
Total occlusions in major vessels and/or total occlusion in stent
-
No visible plaque in non-stented segments on CCTA
-
Incidental findings requiring immediate follow-up or management (e.g., Aortic dissection, findings suggestive of cancer, pulmonary embolism)
-
Findings that require further imaging follow-up within 1 year (e.g., pulmonary nodules ≥6 mm)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Bras de soins habituels
|
|
|
Expérimental: Unblinded AI-CPA Test Arm
|
REWRITE-CAD will provide AI-CPA results |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)
Délai: Enrollment to 90 days
|
Enrollment to 90 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)
Délai: Enrollment through end of study at 21 months
|
Enrollment through end of study at 21 months
|
|
|
Percentage of participants who initiate or intensify cardiovascular disease prevention medication therapy
Délai: Enrollment through end of study at 21 months
|
Enrollment through end of study at 21 months
|
|
|
Time to intensification of LLT
Délai: Enrollment through end of study at 21 months
|
Enrollment through end of study at 21 months
|
|
|
% Undergoing lipid testing
Délai: Enrollment through end of study at 21 months
|
Enrollment through end of study at 21 months
|
|
|
LDL-C changes
Délai: Enrollment through end of study at 21 months
|
Enrollment through end of study at 21 months
|
|
|
Changes in Plaque Volumes
Délai: Enrollment through end of study at 21 months
|
Enrollment through end of study at 21 months
|
|
|
Referral to invasive coronary angiography (ICA) and coronary revascularization
Délai: Enrollment through end of study at 21 months
|
Enrollment through end of study at 21 months
|
|
|
Percentage of participants classified as high adherence on the 8-item Morisky Medication Adherence Scale (MMAS-8)
Délai: Enrollment through end of study at 21 months
|
Evaluated using the 8-item MMAS-8 questionnaire. Total scores range from 0 to 8, where higher scores indicate better adherence. High adherence is defined as achieving a score of 8, medium adherence as 6 to <8, and low adherence as <6. |
Enrollment through end of study at 21 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CP-912-001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .