Evaluation of cardio protective effects of intra coronary morphine in patients with STEMI referred for PPCI.
Design
A clinical trial with the control group, double-blind, randomized, phase 3 on 110 patients. For randomization, a random sequence is used by an epidemiologist by running an online program on the website (https://www.sealedenvelope.com).
Settings and conduct
Patients referred to Shahid Beheshti Hospital of Qom with acute myocardial infarction are divided into two groups using block randomization method. The intervention group underwent percutaneous primary coronary intervention with the drug morphine (5 mg in 3 ml of saline) and the control group received a placebo (3 ml of normal saline). Transthoracic echocardiography was performed on days 1 and 6 and the output The left ventricle will be calculated using the two-way Simpson method. Troponin T level (measured every 12 hours during the first 24 hours and then every 12 hours for the next 48 hours), LVEF measured by echocardiography with the same operator on days 1 and 6 and the clinical result will be evaluated after 3 months.
In this double-blind study, the clinical care and data collector were blind to group assignment and the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion: age older than 18 years; Acute myocardial infarction with ST segment elevation
Exclusion: allergy to morphine; coronary artery bypass grafting; resuscitated cardiac arrest; mechanical ventilation upon arrival; Morphine injection in the emergency room; right ventricular stroke; serious liver failure and Cardiac arrhythmia
Intervention groups
The intervention group underwent percutaneous primary coronary intervention with morphine drug (5 mg in 3 ml of saline) and the control group received placebo (3 ml of normal saline).
Main outcome variables
Coronary Reperfusion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220814055685N1
Registration date:2022-12-10, 1401/09/19
Registration timing:prospective
Last update:2022-12-10, 1401/09/19
Update count:0
Registration date
2022-12-10, 1401/09/19
Registrant information
Name
seyed fakhrodin hejazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2000
Email address
sf-hejazi@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of Intra-coronary morphine vs placebo in the treatment of acute ST-segment elevation myocardial infarction
Public title
Effect of intra coronary morphine in STEMI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
Acute myocardial infarction with STEMI patients
Exclusion criteria:
Known allergy to morphine hydrochloride
Patients with coronary artery bypass grafting
Patients with cardiac arrest are resuscitated
Mechanical ventilation on arrival
Morphine injection in the emergency room
Patients with right ventricular stroke
Serious failure of liver cells
Any cardiac arrythmia
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups using the randomized balanced block method with block sizes of 4 and 6. The random sequence is generated by an epidemiologist by running an online program on the website (https://www.sealedenvelope.com).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the clinical caregiver, and outcome assessor were blinded to the group allocation. In order to hide the concealment from random allocation, we use the method used to implement a random sequence on the participants in the study, such that before the allocation of the individual, the assigned group does not specify. by using non - transparent sealed envelopes with a random sequence in ( Sequentially numbered, sealed, opaque envelopes ) In this method each of the random created on a card is placed in the mail packet, respectively .in order to maintain a random sequence, it is performed on the outer surface of .finally, the envelope of the envelope packets is glued inside the box .at the beginning of registration of the participants, according to the order of eligible participants to study, one of the mail envelopes is unfolded, and the assigned group of the participants is revealed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Qom University of Medical Sciences
Street address
Shahid Lavasani St
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2022-06-12, 1401/03/22
Ethics committee reference number
IR.MUQ.REC.1401.070
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction with ST elevation
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Coronary reperfusion
Timepoint
One and Six Day after the intervention
Method of measurement
Trans thoracic echocardiography
Secondary outcomes
1
Description
Cardiac enzyme(troponin)
Timepoint
Every 12 hours during the first 24 hours and then every 12 hours for the next 48 hours
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: One dose of morphine sulfate hydrochloride with a dose of 5 mg with a single administration slowly over a period of one to two minutes at the beginning of primary PCI inside the coronary arteries.
Category
Treatment - Drugs
2
Description
Control group: Patients undergoing PPCI receive 3 cc of normal saline intracoronary after receiving routine treatment.