Takotsubo Registry
Paraules clau
Resum
Descripció
Registry outreach will begin with an informational and inspirational website and will utilize social media and patient-driven activism through Facebook, blogs and Twitter modalities that have demonstrated efficiencies in other patient-centered research efforts. Subjects will upload specific clinical materials into Cedar-Sinai's web-enabled cloud storage and which will be screened by trained Smidt Heart Institute physicians. The Registry utilizes on-line, e-consent and enrollment connected to a REDCap database that will allow efficient data input for analysis. All potential subjects who have been diagnosed with Takotsubo or have been informed by their physician that they meet diagnosis criteria, will need to provide information for review that includes: hospitalization records, from the time of Takotsubo event, with laboratory data (particularly -- troponin level), ECG and CTA. Registrants will be asked to respond to annual update surveys.
The goal is to accurately understand the prevalence, recurrence and prospective status of the Takotsubo, to determine which individuals are at risk of reoccurrence or subsequent adverse event and to determine potential treatment targets to develop therapeutic strategies
Primary:
- To establish a large USA-based database for patients with Takotsubo with a convenient and easy to use on-line patient-advocate registry using digital media marketing, Box cloud data access and storage, accurate case adjudication, and automated follow-up.
- Participants will also be offered the option of participating in the Takotsubo Proteomic Registry by providing remote ambulatory Mitra blood samples.
Secondary:
• To establish a clinical trial platform for patient-centered point-of-care trials to improve diagnostics, clinical care and outcomes.
Dates
| Darrera verificació: | 03/31/2019 |
| Primer enviat: | 03/05/2019 |
| Inscripció estimada enviada: | 04/07/2019 |
| Publicat per primera vegada: | 04/09/2019 |
| Última actualització enviada: | 04/28/2019 |
| Publicació de l'última actualització: | 04/30/2019 |
| Data d'inici de l'estudi real: | 01/31/2019 |
| Data estimada de finalització primària: | 01/31/2029 |
| Data estimada de finalització de l’estudi: | 01/31/2029 |
Condició o malaltia
Fase
Criteris d'elegibilitat
| Edats elegibles per estudiar | 18 Years Per a 18 Years |
| Sexes elegibles per estudiar | All |
| Mètode de mostreig | Probability Sample |
| Accepta voluntaris saludables | No |
| Criteris | Inclusion Criteria: - Have received a diagnosis of Takotsubo from their physician and consent to enroll - Submit full medical records needed for Takotsubo adjudication Exclusion Criteria: - Younger than 18 years - Unable to provide informed consent - Unable to provide the necessary documentation needed for screening purposes |
Resultat
Mesures de resultats primaris
1. Number of participants with Prevalence of the Takotsubo [Baseline, Annual follow-up up to 30years]
2. Number of participants with Recurrence the Takotsubo [Baseline, Annual follow-up up to 30years]
3. Annual update surveys will collect data on patient's prospective health status following Takotsubo event [Baseline, Annual follow-up up to 30years]
4. Risk factors affecting which patients, having had one Takotsubo event, will more likely experience a Takotsubo reoccurrence or related subsequent adverse event [Baseline, Annual follow-up up to 30years]
