Non-isotope Based Imaging Modalities vs Technetium-99m Single-Photon Emission Computed Tomography(99mTcSPECT) (MITNECB5)
20 février 2020 mis à jour par: Montreal Heart Institute
Non-isotope Based Imaging Modalities vs 99mTcSPECT to Detect Myocardial Ischemia in Patients at High Risk for Ischemic Cardiovascular Events
SPECT is currently the dominant clinical test for diagnostic and prognostic purposes as well as therapeutic decision-making.
Given the shortage of nuclear reactor-produced Tc, advancing the use of non-isotope based imaging modalities has the potential to change the standard of care for patients with CAD as each one of these technics (CMR, CT, Stress echocardiography) has its own distinct potential advantages over SPECT.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
Obtain a better understanding of the clinical utility of advanced non-isotope-based imaging modalities to detect relevant CAD as potential alternatives to SPECT.
Approximately 450 subjects will be enrolled in total.
Three groups of about 150 patients per group.
Each group will undergo imaging with 2 modalities; Group 1: 99mTcSPECT plus CMR, Group 2: 99mTcSPECT plus CT, Group 3:99mTcSPECT plus stress echocardiography.
All 450 patients will undergo standard invasive coronary angiography following completion of non-invasive imaging, except for patients in whom both nuclear and non-nuclear imaging modalities reveal a normal result confirming the absence of significant coronary artery disease (i.e invasive angiography would not be clinically indicated and FFR would be considered to be above 0.8).
Thrombolysis in Myocardial Infraction (TIMI) flow will be measured in all patients undergoing angiography, and fractional flow reserve (FFR) will be measured in all patients except those with TIMI flow =0, 1 and 2. All imaging procedures must be completed within 6 weeks.
All patients will have a follow-up visit at 6 months after enrollment.
During the 6 month follow-up visit major adverse cardiovascular events will be collected and adjudicated by a clinical endpoint committee (CEC).
Type d'étude
Observationnel
Inscription (Réel)
467
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.
Lieux d'étude
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Quebec
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Montreal, Quebec, Canada
- Montreal Heart Institute
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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 à 87 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Approximately 450 patients across Canada.
Patients will be identified after a clinically indicated SPECT for evaluation of myocardial ischemia.The investigator will assign the patient in one of the three groups based on his medical assessment and availability of equipment at the centre.
La description
Inclusion Criteria:
- clinically indicated request for SPECT
- ability to undergo at least one of three non-nuclear imaging tests; CMR, CT or Stress Echocardiography
- History of recent symptoms suggestive of myocardial ischemia
- High risk for ischemic cardiovascular events
Exclusion Criteria:
- severely reduced systolic function (LV ejection fraction less than 35%)
- Recent (less than 3 days) acute coronary syndrome including acute myocardial infarction
- contraindications to dipyridamole SPECT including : i)severe reactive airway disease; ii) less than 3 days post Myocardial Infarction - Acute Coronary Syndrome (MI-ACS); iii) high-grade Atrioventricular block (AV block); iv)allergy to dipyridamole or theophylline; v) caffeine within 12 hours; vi) theophylline use within 48 hours; vii) severe claustrophobia; or viii) women who may be pregnant
- kidney dysfunction (i.e estimated Glomerular Filtration Rate (eGFR) less than 45)
- use of investigational drug or device within 30 days of screening visit
- Coronary Artery Bypass Graft(s) surgery (CABG)
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
Cohortes et interventions
Groupe / Cohorte |
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Diagnosis
Group 3: 99mTCSPECT plus stress echocardiography
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group 1 : diagnosis
Group 1: 99mTcSPECT plus CMR
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Group 2: diagnosis
Group 2: 99mTcSPECT plus CT
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality
Délai: baseline
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The overall accuracy is calculated as the probability that a subject is correctly classified (presence of significant CAD or not) by non-invasive imaging modality.
The standard of truth is presence of significant CAD or not according to the invasive fractional flow reserve (FFR)
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baseline
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Sensitivity of "significant CAD" according to non-invasive imaging modality
Délai: baseline
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The sensitivity is calculated as the probability that a subject with presence of significant CAD according to FFR is correctly identified as such by non-invasive imaging modality
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baseline
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Specificity of "significant CAD" according to non-invasive imaging modality
Délai: baseline
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The specificity is calculated as the probability that a subject with absence of significant CAD according to FFR is correctly identified as such by non-invasive imaging modality
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baseline
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Positive predictive value of "significant CAD" according to non-invasive imaging modality
Délai: baseline
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The positive predictive value is calculated as the probability that a subject with presence of significant CAD according to non-invasive imaging modality truly have significant CAD according to FFR
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baseline
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Negative predictive value of "significant CAD" according to non-invasive imaging modality
Délai: Baseline
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The negative predictive value is calculated as the probability that a subject with absence of significant CAD according to non-invasive imaging modality truly does not have significant CAD according to FFR
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Baseline
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Overall accuracy of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Délai: baseline
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baseline
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Sensitivity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Délai: Baseline
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Baseline
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Autres mesures de résultats
Mesure des résultats |
Délai |
|---|---|
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Specificity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Délai: baseline
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baseline
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Positive predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Délai: baseline
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baseline
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Negative predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Délai: baseline
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baseline
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Overall accuracy of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE)
Délai: baseline
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baseline
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Sensitivity of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE)
Délai: baseline
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baseline
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Specificity of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE)
Délai: baseline
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baseline
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Positive predictive value of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE)
Délai: baseline
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baseline
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Negative predictive value of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE)
Délai: baseline
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baseline
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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: Jean-Claude Tardif, M.D, Montreal Heart Institute
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
1 octobre 2012
Achèvement primaire (Réel)
1 mai 2018
Achèvement de l'étude (Réel)
18 avril 2019
Dates d'inscription aux études
Première soumission
18 juillet 2013
Première soumission répondant aux critères de contrôle qualité
24 octobre 2013
Première publication (Estimation)
30 octobre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 février 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 février 2020
Dernière vérification
1 février 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MITNEC B5
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
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