Impact of Stress CT Myocardial Perfusion on Downstream Resources and Prognosis (CTP-PRO)
4 juin 2019 mis à jour par: Gianluca Pontone, MD, PhD, Centro Cardiologico Monzino
Impact of Stress Cardiac Computed Tomography Myocardial Perfusion on Downstream Resources and PROgnosis in Patients With Suspected or Known Coronary Artery Disease: a Multicenter International Study
CT myocardial perfusion imaging (CTP) represents one of the newly developed CT-based techniques but its cost-effectiveness in the clinical pathway is undefined.
The aim of the study is to evaluate the usefulness of combined evaluation of coronary anatomy and myocardial perfusion in intermediate to high-risk patients for suspected CAD or with known disease in terms of clinical decision-making, resource utilization and outcomes in a broad variety of geographic areas and patient subgroups.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Description détaillée
The use of cardiac computed tomography angiography (CCTA) is usually suggested in low to intermediate risk for its diagnostic and prognostic role to rule out CAD with low radiation exposure. In the setting of intermediate to high risk patients, the addition of functional information is prognostically useful and, in patients with previous history of percutaneous coronary intervention (PCI), functional strategy has been shown to be more cost-effective as compared to anatomical assessment CT myocardial perfusion imaging (CTP) represents one of the newly developed CT-based techniques, combining both anatomical and functional evaluation of CAD in a single imaging modality. More recently, stress CTP was shown to provide additional diagnostic value as compared to CCTA alone in intermediate to high risk patients. The purpose of this study will be to evaluate the usefulness and impact of combined evaluation of coronary artery anatomy and myocardial perfusion with CCTA+CTP in intermediate to high risk patients for suspected CAD or with known disease in terms of clinical decision-making, resource utilization, and outcomes in a broad variety of geographic areas and patient subgroups.
CTP-PRO study is a cooperative, international, multicentre, prospective, open-label, randomized controlled study evaluating the cost-effectiveness of a CCTA+CTP strategy versus usual care in intermediate to high risk patients with suspected or known CAD who undergo clinically indicated diagnostic evaluation.
Patients will be screened for study eligibility. Patients meeting all selection criteria will be asked to sign an informed consent document prior to undergoing any study-specific evaluation; then a structured interview will be performed and a clinical history obtained, assessing the presence of common cardiac risk factors, drug therapy (focus on statin, aspirin and/or antiplatelet agent use) and symptoms (typical or atypical angina, to estimate the pre-test likelihood of CAD).
Upon completion of the screening procedure and enrollment, the patients will be randomized 1:1 to the CT-based strategy (Group A) or usual care (Group B). Patient follow-up will be performed at 1 year (± 1 month) and 2 years (± 1 month) by trained interviewers who check medical records or by phone interview collecting the following information: downstream testing; overall radiation exposure; outcomes; cost-effectiveness estimation.
The primary endpoint of the study is the reclassification rate of CCTA in group B due to the addition of CTP. The secondary endpoint will be the comparison between group A and group B in terms of non-invasive and invasive downstream testing, prevalence of obstructive CAD at ICA, revascularization, cumulative ED and overall cost during the follow-up at 1- and 2-years. The tertiary endpoint will be the comparison between each group in terms of MACE and cost-effectiveness at 1- and 2-years.
Type d'étude
Interventionnel
Inscription (Anticipé)
2000
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Consecutive patients (age ≥ 18 years) with known or suspected CAD referred for clinically indicated diagnostic evaluation.
- CCTA has to be performed with the state of art in terms of scanner technology as follow: Revolution CT (GE Healthcare, Milwaukee, WI), CardioGraphe (Arineta, Caesarea, Israel), SOMATOM Force (Siemens, Forchheim, Germany), Brilliance iCT and IQon CT (Philips, Best, Netherlands), Aquilion One Vision (Toshiba Medical Systems Corp., Otawara, Japan).
Exclusion Criteria:
- Performance of any non-invasive diagnostic testing within 90 days before enrollment
- Low to intermediate pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score
- Acute coronary syndrome
- Need for an emergent procedure
- Evidence of clinical instability
- Contra-indication to contrast agent administration and/or impaired renal function
- Inability to sustain a breath hold
- Pregnancy
- Cardiac arrhythmias
- Presence of pace maker or implantable cardioverter defibrillator
- Contra-indications to the administration of sub-lingual nitrates, beta-blockade and adenosine
- Structural cardiomyopathy outside of suspected or know ischemic heart disease
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: CCTA Strategy
CCTA will be performed with one of the latest generation scanners.
A stenosis > 50% will be considered as significant from an anatomical point of view.
For coronary stents, degree of intrastent restenosis will be evaluated by visual assessment of intraluminal contrast density.
ISR > 50% will be considered as significant from an anatomical point of view.
For CABG, each graft will be visually evaluated and scored as patent, non-significant stenosis ≤ 50%, significant stenosis > 50%, or occluded.
For patients with positive CCTA results, additional stress CTP will be performed subsequently.
If indicated, vasodilatation will be induced with i.v.
adenosine injection or regadenoson.
Static or dynamic CTP will be performed according to local practice and scanner technology available.
For all patients with previous history of MI the presence of reversible ischemia will be obtained by the comparison between rest and stress perfusion.
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When judged indicated, functional assessment with stress CTP perfusion will be performed on top of CCTA.
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Comparateur actif: Standard of care Strategy
Patients randomized to this group will be evaluated according to current clinical guidelines with the following approaches: (a) stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET; (b) direct referral to ICA.
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(a) functional non-invasive tests (stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET) as a gatekeeper for ICA; (b) direct referral to ICA.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reclassification rate of CCTA in group B due to the addition of CTP
Délai: 30 days.
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For each enrolled patient in whom both CCTA and stress CTP will be performed, the endpoint review committee will use data from coronary CTA and CTP, along with the clinical data to determine the management plan using the following criteria: (a) optimal medical therapy, (b) more non-invasive information required, (c) invasive evaluation required, (d) revascularization treatment (PCI or CABG or hybrid treatment).
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30 days.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Downstream non-invasive testing
Délai: 1- and 2-years.
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Comparison between group A and group B in terms of number of non-invasive downstream testing (Exercise EKG, Stress-Echo, SPECT, Stress CMR, PET) or invasive testing (invasive coronary angiography) performed after the randomization.
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1- and 2-years.
|
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Downstream invasive testing
Délai: 1- and 2-years.
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Comparison between group A and group B in terms of number of downstream invasive testing (invasive coronary angiography) performed after the randomization.
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1- and 2-years.
|
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Prevalence of obstructive CAD at ICA
Délai: 1- and 2-years.
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Comparison between group A and group B in terms of number of patients with obstructive CAD at ICA.
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1- and 2-years.
|
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Revascularization
Délai: 1- and 2-years.
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Comparison between group A and group B in terms of number of patients treated with revascularization (PCI or CABG or hybrid treatment).
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1- and 2-years.
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Effective Dose
Délai: 1- and 2-years.
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Comparison between group A and group B in terms of cumulative Effective Dose (ED), measured in mSv, due to non-invasive or invasive testing performed after randomization.
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1- and 2-years.
|
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Overall costs related to downstream diagnostic tests.
Délai: 1- and 2-years.
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Comparison between group A and group B in terms of overall costs of downstream diagnostic tests (sum of costs of all diagnostic tests performed after randomization), expressed in Dollars, according to local reimbursement.
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1- and 2-years.
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Hospitalization for cardiac reason
Délai: 1- and 2-years.
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Comparison between group A and group B group in terms of number of patients that needed hospitalization for cardiac reason.
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1- and 2-years.
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Unstable angina
Délai: 1- and 2-years.
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Comparison between group A and group B group in terms of number of patients that needed hospitalization for unstable angina (defined according to 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation.
Eur Heart J 2016:37,267-315).
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1- and 2-years.
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Non-fatal myocardial infarction
Délai: 1- and 2-years.
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Comparison between group A and group B group in terms of number of patients that experienced non-fatal myocardial infarction (defined according to Fourth universal definition of myocardial infarction, 2018.
Eur Heart J 2019:40,237-269).
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1- and 2-years.
|
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Cardiac death
Délai: 1- and 2-years.
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Comparison between group A and group B group in terms of number of patients that experienced death because of immediate cardiac cause (e.g., MI, low-output failure, fatal arrhythmia) or vascular cause (e.g., cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause).
Unwitnessed death and death of unknown cause will be classified as cardiovascular death.
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1- and 2-years.
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MACE (Major adverse cardiovascular events)
Délai: 1- and 2-years.
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MACE will be defined as a combined endpoint of unstable angina, nonfatal MI, and cardiac death.
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1- and 2-years.
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Cost-effectiveness ratio
Délai: 1- and 2-years.
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Cost-effectiveness ratio will be calculated according to the following equation: (Index test cost + downstream diagnostic tests cost) / projected remaining life expectancy.
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1- and 2-years.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: U. Joseph Schoepf, MD, Medical University of South Carolina
- Chercheur principal: Gianluca Pontone, MD, PhD, Centro Cardiologico Monzino, IRCCS
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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- Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; ESC Scientific Document Group. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019 Jan 14;40(3):237-269. doi: 10.1093/eurheartj/ehy462. No abstract available.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 juin 2019
Achèvement primaire (Anticipé)
1 juin 2022
Achèvement de l'étude (Anticipé)
1 octobre 2022
Dates d'inscription aux études
Première soumission
30 mai 2019
Première soumission répondant aux critères de contrôle qualité
4 juin 2019
Première publication (Réel)
6 juin 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 juin 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 juin 2019
Dernière vérification
1 juin 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R993/19-CCM 1044
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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 .