Study of safety and efficacy of transplantation of platelet extracted mitochondria in heart ischemic stroke, Clinical trial phase 1 and 2

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210920052524N1

Enrollment

Registered

2021-09-22

Start date

2021-10-23

Completion date

Unknown

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Ischemia. Acute ischemic heart disease, unspecified

Interventions

Intervention 1: Intervention group: In the intervention group, platelets derived mitochondrial is transplanted. After preparing the patient, the extracted mitochondria are injected into the coronary a

Eligibility

Sex/Gender

All

Age

45 Years to 70 Years

Inclusion criteria

Inclusion criteria: Participants, their close relatives or lawyers are able to sign a consent form; Patients with recent myocardial ischemia within 24 hours Candidate for interventional treatment. Ejection fraction less than or equal to 41% (EF = 41%). The age range is between 45-70 years Both Genders

Exclusion criteria

Exclusion criteria: Patients with mitochondrial disorders. Patients with diabetes Patients with renal failure. Pregnant women Patients with cancer are not included in the study.

Design outcomes

Primary

Measure	Time frame
Cardiac arrhythmia. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: Based on diagnostic tests and physician reports.;Non-fatal heart ischemia. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: Based on diagnostic tests and physician reports.;Fever and shivering. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: Thermometer.;Vital signs change. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: Barometer and diagnostic tests.;Death. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: Patients records.;Cardiac enzymes Creatine kinase MB, cardiac troponin I. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: laboratory kits.;Re-hospitalization. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: According to patient file.	—

Measure

Time frame

Cardiac arrhythmia. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: Based on diagnostic tests and physician reports.;Non-fatal heart ischemia. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: Based on diagnostic tests and physician reports.;Fever and shivering. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: Thermometer.;Vital signs change. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: Barometer and diagnostic tests.;Death. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: Patients records.;Cardiac enzymes Creatine kinase MB, cardiac troponin I. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: laboratory kits.;Re-hospitalization. Timepoint: 24 hours and one week after mitochondrial transplantation. Method of measurement: According to patient file.

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Secondary

Measure	Time frame
Left Ventricular Ejection Fraction (LVEF). Timepoint: 3 and 6 months after mitochondrial transplantation. Method of measurement: Echocardiography.;Left Ventricular End Diastolic Volume Index (LVEDVI). Timepoint: 3 and 6 months after mitochondrial transplantation. Method of measurement: Echocardiography.;Left Ventricular End Systolic Volume Index (LVESVI). Timepoint: 3 and 6 months after mitochondrial transplantation. Method of measurement: Echocardiography.;Patient physical activity. Timepoint: 3 and 6 months after mitochondrial transplantation. Method of measurement: The Tests such as six-minute walk test and a treadmill test.	—

Measure

Time frame

Left Ventricular Ejection Fraction (LVEF). Timepoint: 3 and 6 months after mitochondrial transplantation. Method of measurement: Echocardiography.;Left Ventricular End Diastolic Volume Index (LVEDVI). Timepoint: 3 and 6 months after mitochondrial transplantation. Method of measurement: Echocardiography.;Left Ventricular End Systolic Volume Index (LVESVI). Timepoint: 3 and 6 months after mitochondrial transplantation. Method of measurement: Echocardiography.;Patient physical activity. Timepoint: 3 and 6 months after mitochondrial transplantation. Method of measurement: The Tests such as six-minute walk test and a treadmill test.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehryar Habibi Roudkenar

Rasht University of Medical Sciences

Roudkenar@gums.ac.ir+98 13 3336 8540

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026