Intra-coronary administration of tacrolimus prior to primary coronary intervention attenuates infarct size and improves left ventricular function in patients with ST-segment Elevation Myocardial Infarction
| ISRCTN | ISRCTN38455499 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38455499 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/08/2013
- Registration date
- 11/09/2013
- Last edited
- 08/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Studies have previously shown that cyclosporine therapy effectively reduced left ventricular infarction size and preserved left ventricular function after acute myocardial infarction (heart attack). In view of the fact that immune and inflammatory reactions are one of the major contributors to death of the cells that make up the cardiac muscle (cardiomyocytes) after acute myocardial infarction and that the drug tacrolimus is more effective than cyclosporine, we think that tacrolimus may limit the extent of myocardial infarction and improve left ventricular function after heart attack. To test this idea, animal studies were conducted which showed promising results, raising the need for a study to investigate the impact of tacrolimus when given as an injection directly into the heart on improving reperfusion rate, left ventricular function and clinical outcome in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.
Who can participate?
Men and women, aged between 20 and 80 years old, with acute ST-segment elevation myocardial infarction occurring within 12 hours and receiving primary percutaneous coronary intervention (PCI).
What does the study involve?
The participants are randomly allocated to one of the two groups. In the study group, tacrolimus is injected directly into the heart before primary PCI. In the control group, normal saline is injected directly into the heart before primary PCI.
What are the possible benefits and risks of participating?
The possible benefits are improvement of heart function and reduction of adverse outcomes. Possible risks include reduced kidney function, neurotoxicity (affecting brain cells), hyperglycemia (increased blood sugar level) and diarrhoea.
Where is the study run from?
Six medical centres located in China and Taiwan.
When is the study starting and how long is it expected to run for?
The study started in September 2013 and it is expected to run for 4 years. The trial will be recruiting participants for 3 years, and all patients will be followed up at least 1 year.
Who is funding the study?
Chang Gung Memorial Hospital (Taiwan).
Who is the main contact?
Dr Hon-Kan Yip
Contact information
Scientific
123, Ta Pei Road
Niao Sung District
Kaohsiung
833
Taiwan
Study information
| Study design | Prospective randomized double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet: Hon-Kan Yip/ Chang Gung Memorial Hospital. E-mail: han.gung@msa.hinet.net |
| Scientific title | Intra-COronary Administration of Tacrolimus prior to first-balloon attenuates infarct size and improves left ventricular function in patients with ST-segment Elevation Myocardial Infarction (COAT-STEMI) undergoing primary coronary intervention: a double-blind, placebo-controlled, randomized, multi-center clinical trial |
| Study objectives | Tacrolimus may limit the extent of myocardial infarction and improve left ventricular function in the setting of acute myocardial infarction. |
| Ethics approval(s) | Chang Gung Memorial Hospital, 29/07/2013, ref: 102-1228A3 |
| Health condition(s) or problem(s) studied | Acute ST segment elevation myocardial infarction |
| Intervention | Study arm- 600 participants. Intra-coronary transfusion of tacrolimus before primary percutaneous coronary intervention for acute myocardial infarction. Control arm-600 participants. Intra-coronary transfusion of normal saline before primary percutaneous coronary intervention acute myocardial infarction. The primary percutaneous coronary intervention procedures are the same in both arms and following the clinical practice. The duration of treatment is the same as the procedure of primary percutaneous coronary intervention. All patients will be followed up at least one year. |
| Intervention type | Other |
| Primary outcome measure | Percentage of Thrombolysis In Myocardial Infarction (TIMI)-3 flow post primary percutaneous coronary intervention after the procedure by coronary angiography (the same day). |
| Secondary outcome measures | 1. 30 days mortality 2. One year cardiac mortality 3. One year adverse outcome (including mortality, reinfarction and target vessel revascularization) 4. One year re-hospitalization due to congestive heart failure 5. 6 months improvement of left ventricular function by echocardiography |
| Overall study start date | 01/09/2013 |
| Completion date | 31/08/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1200 |
| Key inclusion criteria | Male and female, age between 20 and 80 years old with acute ST segment elevation myocardial infarction occuring less than 12 hours and receiving primary percutaneous coronary intervention (PCI). |
| Key exclusion criteria | 1. Recent myocardial infarction and stroke within 3 months 2. Receiving immunosupressant, adverse drug reaction for immunosuppressant, cardiogenic shock, active inflammative or infectious disease 3. Pregnant or breast feeding women 4. Liver cirrhosis 5. Hemodialysis patients 6. Patients receiving organ transplant 7. Malignancy 8. Life span less than 1 year |
| Date of first enrolment | 01/09/2013 |
| Date of final enrolment | 31/08/2016 |
Locations
Countries of recruitment
- China
- Taiwan
Study participating centres
Niaosng District
Kaohsiung City
83301
Taiwan
Pingtung City
90
Taiwan
Sanmin District
Kaohsiung City
807
Taiwan
Zuoying District
Kaohsiung City
813
Taiwan
Taikang Vil.
Liuying District
Tainan City
376
Taiwan
Xiamen
-
China
Sponsor information
Hospital/treatment centre
123, Ta Pei Road
Niao Sung District
Kaohsiung
833
Taiwan
| Website | http://www.cgmh.org.tw |
|---|---|
"ROR" |
https://ror.org/02verss31 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
08/04/2016: Five additional trial participating centres have been added.
