- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00614354
Study of 99mTc-glucarate to Detect Acute Coronary Syndrome in Chest Pain Patients.
Phase II Study of 99mTc-glucarate in Chest Pain Patients Suspected With ACS With no Obvious Signs of AMI and With Known Previous CAD.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Acute coronary syndrome encompasses a range of coronary artery diseases, including unstable angina and both ST-segment elevation and non-ST-segment elevation myocardial infarction (MI). Differentiating ACS from noncardiac chest pain remains a challenge in the emergency department (ED). Myocardial perfusion imaging (MPI) for ischemia has been used to rule ACS in or out among chest pain patients with nondiagnostic ECGs upon presentation to the ED. Several studies have shown a high negative predictive value of MPI for ruling out acute ischemia in the emergency setting. Although myocardial imaging with perfusion agents provides important information for risk-stratifying stable post-ACS patients, this method is of limited value in patients with prior history of CAD, since these patients will often have abnormal resting perfusion patterns, thereby precluding the ability to differentiate old infarcts from new ischemic events. 99mTc-glucarate does not detect old MIs and thus should provide an improvement in specificity in the imaging of ACS patients with previous CAD.
This study proposes to extend the evaluation of 99mTc-glucarate imaging by studying its ability to detect ACS in chest pain patients with no obvious signs of AMI but with known CAD, in the setting of the ED. Unlike MPI, 99mTc-glucarate imaging will not detect old MIs, thereby providing an advantage in specificity of the technique.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Alabama
-
Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama at Birmingham
-
-
Connecticut
-
New Haven, Connecticut, Estados Unidos, 06520
- Yale University
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44106
- University Hospital Case Medical Center
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Chest pain of recent onset (less than 24 hours) and of greater than 5-minute duration, consistent with ACS;
- History of CAD;
- Creatinine level less than 3.5 mg per deciliter;
- Female patients who are: surgically sterile (hysterectomy or bilateral tubule libation), at least one year post-menopausal, or have a negative pregnancy test on the day of treatment; and
- Written informed consent.
- This research is being supported by the NIH/NHLBI which requires a minimum 50% participation from women. Efforts should be made to enroll equal numbers of men and women at each clinical site.
Exclusion Criteria:
- ECG changes diagnostic of AMI;
- A cardiac revascularization procedure within the last 2 weeks (non-revascularization procedures such as cardiac catheterization, stress test or echocardiography are acceptable);
- An alternate diagnosis more probable than ACS;
- Presence of pericarditis, myocarditis, acute aortic dissection, pneumothorax, or pulmonary embolism (PE);
- Patients with uncontrolled severe heart failure at the time of enrollment (NYHA class III and IV).
- Other serious or life-threatening disease that might preclude a subject from completing this study;
- Clinically essential procedures with which this protocol may interfere;
- Previous 99mTc-based diagnostic test within the last 24 hours;
- Female subjects who are pregnant or lactating;
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 1
|
Patients will receive a single 22 - 27 mCi bolus intravenous dose of 99mTc-glucarate solution, as soon as possible after their arrival in the emergency department or the chest pain center
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Readers will assess images as either positive or negative and note the location of uptake.
Periodo de tiempo: Immediately and end of enrolement
|
Immediately and end of enrolement
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Albert J. Sinusas, MD, Yale University
- Silla de estudio: Diwakar Jain, MD, Drexel University
- Investigador principal: Prem Soman, MD, Ph.D., University of Pittsburgh
- Investigador principal: Ami E Iskandrian, MD, University of Alabama at Birmingham
- Investigador principal: Robert S Jones, MD, University Hospitals Cleveland Medical Center
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MTTI ACS 201
- 5R44HL062770-06 (Subvención/contrato del NIH de EE. UU.)
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. .
Ensayos clínicos sobre 99mTc-glucarate solution
-
Molecular Insight Pharmaceuticals, Inc.TerminadoCancer de prostataEstados Unidos
-
Peking Union Medical College HospitalTerminado
-
British Columbia Cancer AgencyCanadian Institutes of Health Research (CIHR); Lawson Health Research Institute; Centre for Probe Development and Commercialization y otros colaboradoresTerminado
-
Peking Union Medical College HospitalReclutamiento
-
Xijing HospitalAún no reclutandoTumor gastrointestinal 99mTc-FAPI positivo
-
Mayo ClinicReclutamientoEstenosis aórtica | Amiloidosis por transtiretina | Amiloidosis cardíaca por transtiretina | Miocardiopatía amiloide por transtiretinaEstados Unidos
-
Fifth Affiliated Hospital, Sun Yat-Sen UniversityPeking UniversityDesconocidoCáncer de esófago | Diagnostica enfermedad | Metástasis de ganglios linfáticosPorcelana
-
Tomsk National Research Medical Center of the Russian...Uppsala UniversityTerminadoMujer con cáncer de mamaFederación Rusa
-
Peking UniversitySun Yat-sen University; China-Japan Union Hospital, Jilin UniversityTerminado
-
Tomsk National Research Medical Center of the Russian...Uppsala UniversityTerminadoFemenino | Cáncer de mama HER2 positivoFederación Rusa