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|ClinicalTrials.gov Identifier: NCT03910569|
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : May 1, 2019
|Condition or disease|
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
- 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.
• To establish a clinical trial platform for patient-centered point-of-care trials to improve diagnostics, clinical care and outcomes.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Smidt Heart Institute Takotsubo Registry|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||February 2029|
|Estimated Study Completion Date :||February 2029|
- Number of participants with Prevalence of the Takotsubo [ Time Frame: Baseline, Annual follow-up up to 30years ]Prevalence of the Takotsubo will be measured annually. Change from baseline will be assessed.
- Number of participants with Recurrence the Takotsubo [ Time Frame: Baseline, Annual follow-up up to 30years ]Recurrence the Takotsubo will be measured annually. Change from baseline will be assessed.
- Annual update surveys will collect data on patient's prospective health status following Takotsubo event [ Time Frame: Baseline, Annual follow-up up to 30years ]Prospective statusof the Takotsubo will be measured annually. Change from baseline will be assessed.
- Risk factors affecting which patients, having had one Takotsubo event, will more likely experience a Takotsubo reoccurrence or related subsequent adverse event [ Time Frame: Baseline, Annual follow-up up to 30years ]Risk factors for reoccurrence or subsequent adverse event will be collected annually.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910569
|Contact: Ying Mou, PhD||310-248-7669||Ying.Mou@cshs.org|
|Contact: Sophie Yoo, MS||424-315-4306||Jihye.Yoo@cshs.org|
|United States, California|
|Cedars Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90005|
|Contact: Janet Perkins|
|Study Director:||C. Noel Bairey Merz, MD, FACC||Cedars-Sinai Medical Center|