Evaluate the Effectiveness and Cost of Stress Cardiac Magnetic Resonance Imaging (MRI) for Non-invasive Evaluation of Lesions Discovered on Computed Tomography Angiography (CCTA) (DSTAT)
Dual-Source CT and STress Cardiac Magnetic Resonance Assessment in the Triage of Patients With Suspected Acute Coronary Syndromes (D-STAT)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Non-invasive evaluation of coronary anatomy via multi-slice computed tomography with coronary CT angiography (CCTA) has been shown to provide rapid and accurate non-invasive coronary angiography. Although CCTA can be rapidly and safely performed and despite improving our ability to image coronary arteries in this noninvasive fashion, the limitation of CCTA is lack of physiological information in intermediate lesions, i.e., if a patient has a blockage of 40-60% on CCTA in an artery, it is not possible to know if this is what causes symptoms in a patient. This limitation is currently being overcome by stress testing, commonly with perfusion imaging (nuclear stress test). However, disadvantages of nuclear stress testing include long testing times (usually > 4 hours) and use of radiation. Patients with intermediate/uninterpretable lesions on CCTA will be randomized to MPI or MRI.
The endpoints of the study are:
Primary outcome variables:
1. Length of ED stay until definitive diagnosis (time from ED triage until definitive diagnosis).
Secondary outcome variables will include:
- Cost of care of an early diagnostic strategy utilizing stress CMR vs. standard care (costs incurred during index hospitalization and 30 day follow up period) in patients with intermediate lesions of CTA.
- Accuracy of CTA + stress CMR in prediction of occurrence of major adverse cardiac events (MACE) during a 3 month follow-up period, compared to the standard care (CTA + stress/rest MPI): cardiac death, acute myocardial infarction, need for coronary artery revascularization, need for admission or treatment for documented CAD.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Michigan
-
Royal Oak, Michigan, Estados Unidos, 48073
- William Beaumont Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients with chest pain or other symptoms suggestive of acute cardiac ischemia.
- Low risk TIMI risk score (ie. ≤3)
- Able to provide informed consent
- Age equal to or greater than 18 years.
Exclusion Criteria:
- Electrocardiographic evidence of ischemia, including acute STEMI (ST elevation equal to or greater than 1mm in two or more leads), ST segment depression and/or T wave inversion (not known to be old), or attending physician clinical decision for immediate invasive evaluation.
- Positive cardiac biomarkers (troponin, myoglobin, and/or creatinine phosphokinase MB fraction).
- Presence of pre-existing CAD (prior myocardial infarction, prior angiographic evidence of significant CAD, prior coronary bypass surgery) or cardiomyopathy (ejection fraction < 45%)
- Renal insufficiency (creatinine ≥1.6) or renal failure requiring dialysis.
- Atrial fibrillation or other markedly irregular rhythm.
- Inability or refusal to provide informed consent.
- Psychological unsuitability or extreme claustrophobia.
- Pregnancy or unknown pregnancy status.
- Age less than 18 years.
- Clinical instability as deemed by the attending physician; including cardiogenic shock, hypotension (systolic blood pressure < 90 mmHg), refractory hypertension (systolic blood pressure > 180 mmHg), sustained ventricular or atrial arrhythmia requiring intravenous medications.
- Patients with known allergy to iodine or shellfish.
- Inability to tolerate beta blockers, including those with COPD or asthma requiring maintenance inhaled bronchodilators or steroids, complete heart block, second-degree atrioventricular block.
- Computed tomography imaging, or contrast administration, within the past 48 hours.
- Use of Viagra or Cialis in the past 24 hours.
- Patients with known allergy to gadolinium, x-ray dye, Persantine
- Extreme claustrophobia.
- Patients with metal implants that prevent MRI scanning
- Patients with a body weight > 400 lbs
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kavitha Chinnaiyan, MD, William Beaumont Hospitals
- Director de estudio: Gilbert Raff, MD, William Beaumont Hospitals
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2007-085
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. .