evaluation of microvascular dysfunction in patients with Takotsubo syndrome

Phase 4

Recruiting

• Conditions: takotsubo syndrome; takotsubo syndrome,Microvascular Angina,Coronary spasm angina; D054549

• Registration Number: JPRN-jRCT1032230520
• Lead Sponsor: Ken Kato

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-19
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

This clinical trial sets two stages of selection criteria, primary registration and secondary registration, and targets patients who meet all the criteria at each stage. Primary registration is conducted for patients suspected of having Takotsubo syndrome. Secondary registration is conducted after catheter examination.

Primary Registration:

1, Adults aged 18 and over at the time of consent acquisition.
2, Patients who have received sufficient explanation about participating in this trial, have a full understanding, and have obtained written consent by their own free will or that of a proxy.
3, Patients who are hospitalized at Chiba University Hospital, or are scheduled to be hospitalized after a cardiac catheter examination.
4, Patients suspected of having Takotsubo syndrome based on primary examinations (electrocardiogram, echocardiogram, blood tests, etc.).
Secondary Registration:

1, Patients diagnosed with Takotsubo syndrome as a result of cardiac catheter examination, and who can continue to measure IMR, CFR, and CS-Lac/Ao-Lac ratio.

Exclusion Criteria

Patients conflicting with any of the following will not be included in this clinical trial:

1, Patients from whom consent cannot be obtained, either from themselves or a proxy.
2, Patients deemed unsuitable as subjects by the trial responsible (sub) physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes over time (acute phase - after 3 months) in microvascular resistance index by pressurewireX (Abbott)

Secondary Outcome Measures

Name	Time	Method
Changes over time (acute phase - after 3 months)in coronary flow reserve obtained by pressurewireX (Abbott), and the ratio of lactate levels of blood obtained from coronary<br>sinus and aorta over time