Long-term Follow-up Study Following the Approval of Hearticellgram-AMI Administration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hearticellgram-AMI.
- Who it may be relevant to
- Registry conditions: Acute Myocardial Infarction. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Long-term Follow-up Study Following the Approval of Hearticellgram-AMI Administration to Evaluate Its Safety in Patients With Acute Myocardial Infarction
Overview
This Long-term follow-up is designed to evaluate the safety of patient with Acute Myocardial Infarction who had administered Hearticellgram-AMI.
Detailed description
To evaluate the safety for 60 months after a single dose of Hearticellgram-AMI in patients with Acute Myocardial Infarction.
Interventions
- Biological Hearticellgram-AMI
Patients who had administered Hearticellgram-AMI.
Primary outcome measures
- Rate of AESI [Time frame: For 5 years]
Eligibility criteria
Inclusion criteria
- Those who had administered Hearticellgram-AMI
- Those who voluntarily agreed in writing to participate in this investigation
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
South Korea · 1 center
- KIMHYUNSOO Clinic — Seoul
Identifiers
NCT: NCT07400458 · PMC-P-13