Evaluation of the effect of morphine administration on serum CKMB level, ST segment depression and TIMI effect in patients with first acute anterior myocardial infarction who underwent primary coronary angioplasty.
-the effect of morphine on serum CKMB level after primary angioplasty in patients with first acute myocardial infarction
-the effect of morphine on ST-segment depression after primary angioplasty in patients with first acute myocardial infarction
-the effect of morphine on the final coronary TIMI flow of patients with acute myocardial infarction who undergo primary angioplasty
Design
A clinical trial with a control group, double-blind, randomized and phase 2 on 200 patients, and one patient is placed in the control and intervention group
Settings and conduct
Patients with acute anterior myocardial infarction were referred to Shahid Madani Hospital in Tabriz for primary angioplasty divided into two control and intervention groups, and the intervention group received 3 mg of intravenous morphine injection and one milligram of morphine are placed intracoronarily, but the control group will receive distilled water as a placebo. Patients and personnel who inject morphine and those who take blood samples and electrocardiograms are blinded. Blood samples are sent for CKMB levels.
Participants/Inclusion and exclusion criteria
inclusion: typical cardiac chest pain at least 20 minutes / ST segment elevation of at least 1 mm / the first acute myocardial infarction of the patient / myocardial infarction in the last 6 hours / intial TIMI score is 0 or 1 / no morphine injection in the emergency room.exclusion: receiving fibrinolytic / receiving cardiac electric shock / patient resuscitation / patient intubation / having VT or VF arrhythmia / history of CABG / complete heart block / respiratory failure / history of liver cirrhosis / primary TIMI 2 and or more will be excluded from the study.
Intervention groups
patients with acute anterior myocardial infarction who have been referred cath lab for primary angioplasty
Evaluation of the effect of morphine administration on serum CKMB level, ST segment depression and TIMI effect in patients with first acute anterior myocardial infarction who underwent primary coronary angioplasty.
Public title
Effect of morphin in prognose of Anterior MI
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Typical cardiac chest pain lasting at least 20 minutes
ST segment elevation of at least 1 mm repeated in two consecutive leads
Q wave not seen with ST segment elevation
patient's first acute anterior myocardial infarction
A heart attack has occurred in the last 6 hours
initial TIMI score is 0 or 1
no morphine injection in the emergency room or before
Exclusion criteria:
receiving fibrinolytic
receiving cardiac electric shock
resuscitating the patient
being intubated
having VT or VF arrhythmia
history of CABG
complete heart block
respiratory failure
history of liver cirrhosis
early TIMI flow 2 or more
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted randomization(Random allocation rule)/Random allocation software(SAS)/In order to hide, the method of Numbered drug containers will be used
Blinding (investigator's opinion)
Double blinded
Blinding description
- Apart from knowing the type of study and participation in the study and possible complications, the participant is completely blinded to which group he is in and what the results of the data are like.
- The health personnel have no knowledge of the type and process of the study and only follow the orders
- Those responsible for data collection and those who evaluate the outcome are completely blinded to the study process
Placebo
Used
Assignment
Parallel
Other design features
In this study, the dose of morphine received was different compared to similar studies, and also three cases of TIMI FLOW, ST and CKMB levels will be evaluated together for the first time.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Azadi St., Golbad St., University St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166615573
Approval date
2022-12-05, 1401/09/14
Ethics committee reference number
IR.TBZMED.REC.1401.802
Health conditions studied
1
Description of health condition studied
Acute Anterior ST Elevatiom Myocardial Infarction
ICD-10 code
I21.0
ICD-10 code description
ST elevation (STEMI) myocardial infarction of anterior wall
Primary outcomes
1
Description
coronary timi flow
Timepoint
in angiographic last view
Method of measurement
According to the international definition of coronary Timi Flow
Secondary outcomes
1
Description
The degree of ST segment depression in the patient's ECG
Timepoint
90 minutes after the patient enters the CCU
Method of measurement
Obtaining an ECG by the patient's nurse and reading it by a cardiologist
Intervention groups
1
Description
Intervention group: For this group, morphine sulfate is injected in the lab coat and on the angiography bed with a dose of 1 mg intracoronary and 3 mg intravenous. 3 mg of intravenous morphine diluted with 5 cc of distilled water and 1 mg of intracoronary morphine diluted with 5 cc of distilled water and injected only once at the beginning of angioplasty in the doses described. 90 minutes after angioplasty, an electrocardiogram was taken in ccu and compared with the initial tape in terms of ST segment loss. During admission to the ccu and at an interval of 8 hours, blood is taken from the patient up to 3 times and sent to the laboratory to evaluate the level of ckmb. The angiography films are given a TIMI FLOW score according to the final TIMI flow.
Category
Treatment - Drugs
2
Description
Control group: Control group: This group does not receive any morphine and on the angiography bed, only 5 cc of distilled water is injected intracoronary and 5 cc of distilled water intravenously. 90 minutes after angioplasty in the ccu, an ECG is taken from the patients and it is compared with the initial tape in terms of ST segment loss. When entering the ccu and at an interval of 8 hours, the patient's blood is taken 3 times and sent to the laboratory to evaluate the ckmb level. The angiography films will be awarded according to the final TIMI flow by the project manager and the points corresponding to TIMI FLOW will be awarded to them. The implementation of the plan is evaluated and reviewed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Shahid Madani Heart and Vascular Specialist Hospital
Full name of responsible person
Tohid Yahyapoor Talatapeh
Street address
Azadi St., Golbad St., University Quay, Shahid Madani Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166615573
Phone
+98 41 3337 3900
Email
mosharkesh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Assistant of Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahaby
Street address
Azadi St., Golbad St., University Quay, university of medical siences of tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166615573
Phone
+98 41 3337 3900
Email
Tohidyahyapoor1382@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistant of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Research Assistant of Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahaby
Position
Assistant Proffessor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Azadi St., Golbad St., University Quay, Tabriz university of medical sience
City
Tbriz
Province
East Azarbaijan
Postal code
5166615573
Phone
009841333900
Email
Tohidyahyapoor1382@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Assistant of Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahaby
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Azadi St., Golbad St., University Quay,Tabriz university of medical sience
City
Tabriz
Province
East Azarbaijan
Postal code
5166615573
Phone
009841333739003
Email
Tohidyahyapoor1382@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Research Assistant of Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahaby
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Azadi St., Golbad St., University Quay, Shahid Madani Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166615573
Phone
009841333739003
Email
Tohidyahyapoor1382@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD