Protocol summary

Summary
The main cause of left ventricular dysfunction and heart failure following myocardial infarction is left ventricular remodelling and the severity of these changes can predict mortality of the patients. experimental studies have shown that minocycline could predict left ventricular remodeling following myocardial infarction and can have a protective effect on myocardial ischemia/reperfusion. However, human studies are insufficient. This study is designed to investigate the effect of minocycline on left ventricular function following myocardial infarction in patients who reffered to Tehran Heart Center. After obtaining demographic and clinical data, patients will be randomized to receive either minocycline or placebo based on the defined protocol. measurement of Serum levels of MMP-2 and 2D transthoracic echocardiograhy and 2D speckle tracking echocardiography ill be performed ithin 48 hours following PCI and after 6 months to measure the tissue deformation indices. Then the study data will be compared between the study group. In this double-blinded randomized controlled clinical trial, 90 patients with ST-segment elevation myocardial infarction

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201411188698N15
Registration date: 2015-06-22, 1394/04/01
Registration timing: na

Last update:
Update count: 0
Registration date
2015-06-22, 1394/04/01
Registrant information
Name
Azita Hajhossein Talasaz
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66954709
Email address
atalasaz@razi.tums.ac.ir
Recruitment status
Not enough for processing
Funding source
Tehran Heart Center, Tehran university of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of minocycline on the post myocardial infarction left ventricular function in patients with ST-segment elevation myocardial infarction treated by primary percutaneous coronary intervention
Public title
The effect of minocycline on the post myocardial infarction left ventricular function in patients with ST-segment elevation myocardial infarction treated by primary percutaneous coronary intervention
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: 1- Diagnosis of STEMI (chest pain>30 minutes and <12 hr, ST segment elevation in electrocardiogram>1 mm in at least 2 consecutive leads) 2- No history of heart failure 3- Giving consent to enter the study 4- Age>20 and <65 years 5- Successful PCI exclusion criteria: 1- History of myocardial infarction 2- History of cardiac surgery (either CABG or valvular surgery) 3- History of electrophysiological interventions (ablation or device implantation) 4- Presence of cardiogenic shock at the time of admission 5- Chronic diseases with poor survival (malignancy, etc.) 6- Cardiomyopathy or hereditary muscular diseases 7- Chronic renal or hepatic insufficiency 8- new onset left bundle branch block in ECG 9- candidate for antithrombolytic therapy 10- Moderate to severe mitral regurgitation
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran Heart Center
Street address
North Kargar Ave
City
Tehran
Postal code
1411713138
Approval date
2015-02-26, 1393/12/07
Ethics committee reference number
1393-12-A-008

Health conditions studied

1

Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
myocardial infarction specified as acute or with a stated duration of 4 weeks (28 days) or less from onset

Primary outcomes

1

Description
Left ventricular function
Timepoint
Baseline (within 48 hours from PCI) and 6 months later
Method of measurement
Echocardiography

Secondary outcomes

1

Description
Diastolic function
Timepoint
Baseline (within 48 hours from PCI) and 6 months later
Method of measurement
Echocardiography

2

Description
Tissue doppler indices
Timepoint
Baseline (within 48 hours from PCI) and 6 months later
Method of measurement
Color Doppler Echocardiography

Intervention groups

1

Description
Minocycline 50 mg orally at baseline and then 50 mg daily for 5 days
Category
Treatment - Drugs

2

Description
Placebo in the form of the main drug orally at baseline and then daily for 5 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Mojtaba Salarifar
Street address
North Kargar st.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Azita Hajhosein talasaz
Street address
North Kargar st
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Heart Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Alireza Nasiri
Position
Resident of cardiology
Other areas of specialty/work
Street address
North Kargar st.
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 218829731
Email
Alirezanasiri6584@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azita Hajhosein Talasaz
Position
Clinical Pharmacologist
Other areas of specialty/work
Street address
North Kargar st.
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
Email
ahhtalasaz@yahoo.com; atalasaz@ razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Akbar Shafiee
Position
MD, MSc
Other areas of specialty/work
Street address
North Kargar st.
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
Email
Leo71538@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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