evaluation of microvascular dysfunction in patients with Takotsubo syndrome

JRCT ID: jRCT1032230520

Registered date:19/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: takotsubo syndrome
• Date of first enrollment: 19/12/2023
• Target sample size: 12
• Study type: Interventional

Intervention(s)

To evaluate coronary artery microcirculatory resistance and coronary flow reserve changes during th
e acute and recovery phases of patients with Takotsubo syndrome using the CoroFlow system (Abbo
tt). Also, to evaluate changes in microcirculatory resistance by assessing lactate levels in blood sam
ples collected from the coronary sinus and aorta.The acetylcholine stress test is performed during t
he recovery phase to evaluate whether or not coexist coronary spasm.

Outcome(s)

• Primary Outcome: Changes over time (acute phase - after 3 months) in microvascular resistance index by pressurewireX (Abbott)

Secondary Outcome

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
sinus and aorta over time

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Ken Kato
• Secondary Sponsor: Clinical Research Initiation-Fund of Chiba University Hospital