The effect of melatonin on coronary perfusion after PPCI in patients with myocardial infarction
Design
Double blinded, controlled randomized trial
Settings and conduct
Patients with STEMI PPCI candidate referred to Modarres Hospital are divided into two groups. Patients in the case group will receive 3 mg of melatonin before PPCI and control group will receive placebo before PPCI without melatonin.
The patient is not aware of the type of drug received.Doctors who perform PPCI and those who complete patient information are not informed about the type of medication being taken.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at least 18 years old; PPCI for the first 6 hours; STEMI evidence in patient electrocardiogram; blockage of one of the major coronary arteries; verbal Desire and Written Patient Satisfaction.
Exclusion criteria: ESRD; history of autoimmune diseases; patient with severe illness with short prognosis; atrial fibrilation before or after PPCI; pregnancy or breast feeding.
Intervention groups
Case groupe will receive 3 mg of melatonin before PPCI and the control group will receive PPCI without melatonin
Main outcome variables
Changes in coronary artery perfusion
General information
Reason for update
Acronym
MCP
IRCT registration information
IRCT registration number:IRCT20191214045726N1
Registration date:2020-01-15, 1398/10/25
Registration timing:prospective
Last update:2020-01-15, 1398/10/25
Update count:0
Registration date
2020-01-15, 1398/10/25
Registrant information
Name
zahra alipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 3106
Email address
z_alipour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Melatonin on Coronary perfusion after primary percutaneous coronary intervention
Public title
Effect of Melatonin on Coronary perfusion after primary percutaneous coronary intervention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute Myocardial infarction
Age older than 18 years old
PPCI for the first 6 hours
STEMI evidence in patient electrocardiogram
Blockage of one of the major coronary arteries
Verbal desire and written patient satisfaction to participate in the study
Exclusion criteria:
Chronic renal failure
A history of autoimmune disease
Atrial fibrilation
Pregnancy or breast feeding
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients randomly assigned in 1:1 rathio and the computer is classified into two groups of case and control
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Biomedical Research Vice Chancellor for Research of Shahid Beheshti University o