Follow-up Study After Investigator-Initiated Phase I Study of MTC001 for Chronic Ischemic Heart Failure.

JRCT ID: jRCT1030230216

Registered date:11/07/2023

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Chronic ischemic heart failure
• Date of first enrollment: 07/07/2023
• Target sample size: 6
• Study type: Observational

Outcome(s)

Primary Outcome

Occurrence of major cardiovascular events
*: Major cardiovascular events: death, myocardial infarction, stroke, hospitalization/prolonged hospitalization due to worsening heart failure, cardiac perforation, cardiac tamponade, sustained ventricular tachycardia (>30 seconds or hemodynamic collapse)/ventricular fibrillation among serious adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable

Include criteria

1)Patients who received VCF1 in the investigator-initiated phase 1 study (MTC001-2012) and who have consented to this observational study by the end of study participation (52 weeks).
2)Patients who are able to obtain written consent in person.

Exclude criteria

1)Patients who withdrew consent after receiving VCF1 in the investigator-initiated phase I study (MTC001-2012)
2)Patients deemed ineligible by the Principal Investigator or Sub investigator

Related Information

• Primary Sponsor: Machino Takeshi