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Psychosocial Support for Patients With Takotsubo Syndrome

Primary Purpose

Takotsubo Cardiomyopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Takotsubo Support Group
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Takotsubo Cardiomyopathy focused on measuring Takotsubo, Cardiomyopathy, Takotsubo Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - All patients with documented diagnosis of Takotsubo Syndrome greater than 18 years old. Exclusion Criteria: Patients with a diagnosis of Takotsubo Syndrome already undergoing Psychotherapy or those who choose not to participate. Vulnerable populations such as prisoners, non-English speaking subjects, pregnant women, and subjects unable to provide written informed consent will not be included in this research.

Sites / Locations

  • Weill Cornell Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Takotsubo Support Group

Arm Description

Participants diagnosed with Takotsubo Syndrome will be enrolled into the study.

Outcomes

Primary Outcome Measures

Change in anxiety level as measured by the STAI.
State Trait Anxiety Inventory (STAI): Score of 20-39 = Low Anxiety; Score of 40-59 = Moderate Anxiety; Score of 60 - 80 = High Anxiety

Secondary Outcome Measures

Changes in depression as measured by the PHQ-8.
Patient Health Questionnaire depression scale (PHQ-8): Score of 0-2 = No Depression; Score of 3-5 = Mild Depression; Score of 6-8 = Moderate Depression; Score of 9-12 = Severe Depression
Changes in quality of life as measured by the KCCQ.
Kansas City Quality of Life Questionnaire (KCCQ): Score of 0-24 = Very poor to poor quality of life; Score of 25-49 = Poor to fair quality of life; Score of 50-74 = Fair to good quality of life; Score of 75-100 = Good to excellent quality of life

Full Information

First Posted
July 27, 2023
Last Updated
September 27, 2023
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT05977049
Brief Title
Psychosocial Support for Patients With Takotsubo Syndrome
Official Title
Psychosocial Support for Patients With Takotsubo Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study hypothesis is that participants enrolled in a virtual Takotsubo support group will have significantly less anxiety at one year.
Detailed Description
Takotsubo cardiomyopathy, sometimes termed Takotsubo syndrome and "broken heart syndrome," typically presents with symptoms remarkably similar to acute myocardial infarction (MI; heart attack): debilitating chest pain, shortness of breath, and a feeling of doom, among others. Takotsubo was first identified in 1990 in Japan. Most cases occur in older women. During the acute phase, the heart spontaneously undergoes "apical ballooning," changing shape to resemble a "takotsubo," a Japanese octopus trap. In approximately two-thirds of cases, Takotsubo is precipitated by an intense emotional or physical "trigger." Typically, the heart spontaneously reverts to its previous shape within about a month. Initially, it was thought that recurrence was rare. However, more recently, recurrences have been reported in 3-15% of cases. Many patients experience a variety of debilitating cardiac and psychological symptoms long after the initial presentation. There is no known way to prevent a recurrent event and patients are typically anxious about the possibility. Since its inception as a diagnosis, one of the hallmarks of Takotsubo has been the absence of coronary artery plaque. In a surprising finding from 2019, a study of more than 1,000 Takotsubo patients undergoing coronary angiography reported that approximately 1/3 of patients had clinically significant plaque in their coronary arteries; 1/3 had evidence of sub-clinical atherosclerosis; and 1/3 had "clean coronaries," with no observable plaque. Hence, much needs to be learned about this syndrome that may affect as many as 5% of women who have been diagnosed with acute MI. Takotsubo is typically an emotionally challenging and life altering event. Strategies for primary and secondary prevention of coronary artery disease will be discussed in the virtual group sessions. Currently, there is no specialized intervention for patients diagnosed with Takotsubo Syndrome at Weill Cornell Medical Center, either in hospital or after discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Takotsubo Cardiomyopathy
Keywords
Takotsubo, Cardiomyopathy, Takotsubo Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects will be placed in a virtual Takotsubo Support Group once enrolled in the study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Takotsubo Support Group
Arm Type
Other
Arm Description
Participants diagnosed with Takotsubo Syndrome will be enrolled into the study.
Intervention Type
Behavioral
Intervention Name(s)
Takotsubo Support Group
Intervention Description
Participants will undergo virtual group therapy/education. Participants will meet once every other week (at minimum), for 1 - 1.5 hours (on average). The frequency and/or length of the support group sessions may be adjusted according to participants' needs.
Primary Outcome Measure Information:
Title
Change in anxiety level as measured by the STAI.
Description
State Trait Anxiety Inventory (STAI): Score of 20-39 = Low Anxiety; Score of 40-59 = Moderate Anxiety; Score of 60 - 80 = High Anxiety
Time Frame
Baseline, One year
Secondary Outcome Measure Information:
Title
Changes in depression as measured by the PHQ-8.
Description
Patient Health Questionnaire depression scale (PHQ-8): Score of 0-2 = No Depression; Score of 3-5 = Mild Depression; Score of 6-8 = Moderate Depression; Score of 9-12 = Severe Depression
Time Frame
Baseline, One year
Title
Changes in quality of life as measured by the KCCQ.
Description
Kansas City Quality of Life Questionnaire (KCCQ): Score of 0-24 = Very poor to poor quality of life; Score of 25-49 = Poor to fair quality of life; Score of 50-74 = Fair to good quality of life; Score of 75-100 = Good to excellent quality of life
Time Frame
Baseline, One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - All patients with documented diagnosis of Takotsubo Syndrome greater than 18 years old. Exclusion Criteria: Patients with a diagnosis of Takotsubo Syndrome already undergoing Psychotherapy or those who choose not to participate. Vulnerable populations such as prisoners, non-English speaking subjects, pregnant women, and subjects unable to provide written informed consent will not be included in this research.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Glum, BSN, MPA
Phone
212-746-4617
Email
hep2011@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dolores Reynolds, BSN
Phone
212-746-4617
Email
dtr2001@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Cheung, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Glum, BSN, MPA
Email
hep2011@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Dolores Reynolds, BSN
Phone
212-746-4617
Email
dtr2001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Jim Cheung, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Sato, H., et al. (1990) Takotsubo-type cardiomyopathy due to multivessel spasm. In: Kodama, K., Haze, K., Hon M, et al., Eds., Clinical Aspect of Myocardial Injury: From Ischemia to Heart Failure, Kagakuhyouronsha, Tpkyo, 56-64.
Results Reference
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PubMed Identifier
29850871
Citation
Ghadri JR, Wittstein IS, Prasad A, Sharkey S, Dote K, Akashi YJ, Cammann VL, Crea F, Galiuto L, Desmet W, Yoshida T, Manfredini R, Eitel I, Kosuge M, Nef HM, Deshmukh A, Lerman A, Bossone E, Citro R, Ueyama T, Corrado D, Kurisu S, Ruschitzka F, Winchester D, Lyon AR, Omerovic E, Bax JJ, Meimoun P, Tarantini G, Rihal C, Y-Hassan S, Migliore F, Horowitz JD, Shimokawa H, Luscher TF, Templin C. International Expert Consensus Document on Takotsubo Syndrome (Part I): Clinical Characteristics, Diagnostic Criteria, and Pathophysiology. Eur Heart J. 2018 Jun 7;39(22):2032-2046. doi: 10.1093/eurheartj/ehy076.
Results Reference
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PubMed Identifier
32484517
Citation
Napp LC, Cammann VL, Jaguszewski M, Szawan KA, Wischnewsky M, Gili S, Knorr M, Heiner S, Citro R, Bossone E, D'Ascenzo F, Neuhaus M, Franke J, Sorici-Barb I, Noutsias M, Burgdorf C, Koenig W, Kherad B, Sarcon A, Rajan L, Michels G, Pfister R, Cuneo A, Jacobshagen C, Karakas M, Pott A, Meyer P, Arroja JD, Banning A, Cuculi F, Kobza R, Fischer TA, Vasankari T, Airaksinen KEJ, Hauck C, Paolini C, Bilato C, Imori Y, Kato K, Kobayashi Y, Opolski G, Budnik M, Dworakowski R, MacCarthy P, Kaiser C, Osswald S, Galiuto L, Dichtl W, Chan C, Bridgman P, Beug D, Delmas C, Lairez O, El-Battrawy I, Akin I, Gilyarova E, Shilova A, Gilyarov M, Horowitz JD, Polednikova K, Tousek P, Widimsky P, Winchester DE, Galuszka J, Ukena C, Poglajen G, Carrilho-Ferreira P, Di Mario C, Prasad A, Rihal CS, Schulze PC, Bianco M, Crea F, Borggrefe M, Maier LS, Pinto FJ, Braun-Dullaeus RC, Rottbauer W, Katus HA, Hasenfuss G, Tschope C, Pieske BM, Thiele H, Schunkert H, Bohm M, Felix SB, Munzel T, Bax JJ, Bauersachs J, Braunwald E, Luscher TF, Ruschitzka F, Ghadri JR, Templin C. Coexistence and outcome of coronary artery disease in Takotsubo syndrome. Eur Heart J. 2020 Sep 7;41(34):3255-3268. doi: 10.1093/eurheartj/ehaa210.
Results Reference
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Psychosocial Support for Patients With Takotsubo Syndrome

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