NCT03663348

Brief Summary

Takotsubo syndrome is a condition which mimics acute myocardial infarction, and is diagnosed in 1.5% to 2.2% of patients referred to hospital with suspected acute coronary syndrome. It is also known as broken heart syndrome, takotsubo cardiomyopathy, stress cardiomyopathy and apical ballooning cardiomyopathy, among other names. The pathogenesis of this disorder is not well understood. Possible mechanisms include catecholamine excess, coronary artery spasm, microvascular dysfunction, among others. This is a multicenter, nation-wide, observational study of patients who were previously diagnosed with takotsubo syndrome. The investigators aim to use this registry to help plan and carry out further studies and to improve understanding of the pathophysiologic mechanisms of this syndrome. In addition participants will be followed for events, and to monitor quality of life and stress.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Sep 2009Aug 2029

Study Start

First participant enrolled

September 11, 2009

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

19 years

First QC Date

May 16, 2018

Last Update Submit

December 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiac Events

    Medical record review and patient report of repeat takotsubo event, MI, heart failure, unstable angina, chest pain ER visit, cardiovascular death, stroke

    up to 10 years

Secondary Outcomes (4)

  • Quality of life assessed using the Patient Reported Outcome Measurement Information System (PROMIS-10) questionnaire

    every four months up to 10 years

  • Anxiety is assessed using the Hospital Anxiety and Depression Scale (HADS-A)

    every four months up to 10 years

  • Depression assessed using the Patient Health Questionnaire (PHQ-9)

    every four months up to 10 years

  • Perceived stress is measured using the Perceived Stress Scale (PSS-10)

    every four months up to 10 years

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with history of takotsubo syndrome

You may qualify if:

  • Physician diagnosis of takotsubo syndrome
  • Age\>18 years

You may not qualify if:

  • \- Lack of capacity to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesVentricular Dysfunction, LeftVentricular Dysfunction

Central Study Contacts

Harmony Reynolds, MD

CONTACT

Anais Hausvater, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2018

First Posted

September 10, 2018

Study Start

September 11, 2009

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

August 1, 2029

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations