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- Ensayo clínico NCT01972360
Non-isotope Based Imaging Modalities vs Technetium-99m Single-Photon Emission Computed Tomography(99mTcSPECT) (MITNECB5)
20 de febrero de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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).
Tipo de estudio
De observación
Inscripción (Actual)
467
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Quebec
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Montreal, Quebec, Canadá
- Montreal Heart Institute
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 87 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Diagnosis
Group 3: 99mTCSPECT plus stress echocardiography
|
group 1 : diagnosis
Group 1: 99mTcSPECT plus CMR
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Group 2: diagnosis
Group 2: 99mTcSPECT plus CT
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality
Periodo de tiempo: baseline
|
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)
|
baseline
|
Sensitivity of "significant CAD" according to non-invasive imaging modality
Periodo de tiempo: baseline
|
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
|
baseline
|
Specificity of "significant CAD" according to non-invasive imaging modality
Periodo de tiempo: baseline
|
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
|
baseline
|
Positive predictive value of "significant CAD" according to non-invasive imaging modality
Periodo de tiempo: baseline
|
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
|
baseline
|
Negative predictive value of "significant CAD" according to non-invasive imaging modality
Periodo de tiempo: Baseline
|
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
|
Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Overall accuracy of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Periodo de tiempo: baseline
|
baseline
|
Sensitivity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Periodo de tiempo: Baseline
|
Baseline
|
Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
---|---|
Specificity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Periodo de tiempo: baseline
|
baseline
|
Positive predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Periodo de tiempo: baseline
|
baseline
|
Negative predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Periodo de tiempo: baseline
|
baseline
|
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)
Periodo de tiempo: baseline
|
baseline
|
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)
Periodo de tiempo: baseline
|
baseline
|
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)
Periodo de tiempo: baseline
|
baseline
|
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)
Periodo de tiempo: baseline
|
baseline
|
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)
Periodo de tiempo: baseline
|
baseline
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jean-Claude Tardif, M.D, Montreal Heart Institute
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2012
Finalización primaria (Actual)
1 de mayo de 2018
Finalización del estudio (Actual)
18 de abril de 2019
Fechas de registro del estudio
Enviado por primera vez
18 de julio de 2013
Primero enviado que cumplió con los criterios de control de calidad
24 de octubre de 2013
Publicado por primera vez (Estimar)
30 de octubre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de febrero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
20 de febrero de 2020
Última verificación
1 de febrero de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MITNEC B5
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .