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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05977049
Other study ID # 23-04025981
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date January 31, 2025

Study information

Verified date November 2023
Source Weill Medical College of Cornell University
Contact Heather Glum, BSN, MPA
Phone 212-746-4617
Email hep2011@med.cornell.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study hypothesis is that participants enrolled in a virtual Takotsubo support group will have significantly less anxiety at one year.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date January 31, 2025
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Takotsubo Support Group
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.

Locations

Country Name City State
United States Weill Cornell Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Baseline, One year
Secondary 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
Baseline, One year
Secondary 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
Baseline, One year
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