A comparative study of long-term and short-term balloon inflation in terms of TIMI flow after Primary Percutaneous Coronary Intervention in patients with ST elevation MI referred to Imam Khomeini Hospital in Tehran and Heshmat Hospital in Rasht in 1402
A double-blind randomized clinical trial with a control group, on 200 patients for randomization using the block method.
Settings and conduct
This study will be performed in Emam khomeini hospital in Tehran and Heshmat hospital in Rasht.The patients with acute MI brought to hospital will be devided to two groups of prolonged (30 second) and short term balloon inflation based on block randomization.The cardiologist performing PPCI, the person who divides the patients and the data collector and the TIMI flow calculator are blind ,only the cardiologist is aware of the method.
Participants/Inclusion and exclusion criteria
1.Patients over 18 years old
2.Patients with STEMI who is referred and brought to the PPCI center within 12 hours of the onset of clinical symptoms
3.Acceptance of cath lab within 12 hours from the onset of clinical symptoms or within 12-24 hours from the onset of clinical symptoms, provided that cardiac ischemia persists.
Intervention groups
patients in whom the balloon remains inflated for a long time (prolonged balloon inflation during stent deployment group - PBSG). In this group, the stent is inserted once using low pressure balloon inflation for more than 30 seconds
the second group (control group) includes patients with less than 10 second balloon inflation during primary PCI
Main outcome variables
TIMI flow
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240109060666N1
Registration date:2024-05-04, 1403/02/15
Registration timing:registered_while_recruiting
Last update:2024-05-04, 1403/02/15
Update count:0
Registration date
2024-05-04, 1403/02/15
Registrant information
Name
Mahsa Beyranvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2648
Email address
mahsabeyranvand169@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-18, 1403/01/30
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of long-term and short-term balloon inflation in terms of TIMI flow after Primary Percutaneous Coronary Intervention in patients with ST elevation MI referred to Imam Khomeini Hospital in Tehran and Heshmat Hospital in Rasht in 1402
Public title
A comparative study of long-term and short-term balloon inflation in terms of TIMI flow after Primary Percutaneous Coronary Intervention in patients with ST elevation MI referred to Imam Khomeini Hospital in Tehran and Heshmat Hospital in Rasht in 1402
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old
Patients with STEMI who is referred and brought to the PPCI center within 12 hours of the onset of clinical symptoms
Ekg changes in the form of ST segment elevation of more than 1 mm in more than 2 consecutive leads, or having a new left bundle branch block or a true posterior MI.
Acceptance of cath lab within 12 hours from the onset of clinical symptoms or within 12-24 hours from the onset of clinical symptoms, provided that cardiac ischemia persists
Exclusion criteria:
Cardiogenic shock
Intra-aortic balloon pump implan
Extracorporeal membrane oxygenation (ECMO)
Severe valvular disease
History of previous MI
CABG candidate
Ckd as GFR<30
Cardiomyopathy
Congenital heart disease
Malignant arrhythmia
Presence of chronic obstructive pulmonary disease
Inability to give informed consent
A patient who does not need stent implantation during PPCI
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Since the researcher who collects information and analyzes the data is different from the balloon inflating operator, the researcher is blind, but the operator is aware of the balloon inflation time, but this person is not involved in the analysis and evaluation of the results.
The participant is blind to the balloon inflation time
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of Medical sciences
Street address
Keshavarz Boulevard , Dr Gharib St.
City
Tehran
Province
Tehran
Postal code
+981419733134
Approval date
2023-08-29, 1402/06/07
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.361
Health conditions studied
1
Description of health condition studied
TIMI flow
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
TIMI flow
Timepoint
One during the first injection after inserting the Stent ,the second at the end of the procedure while doing the last injection
Method of measurement
TIMI frame count
Secondary outcomes
1
Description
Recurrent MI
Timepoint
40 dayes after the first MI
Method of measurement
By asking the patient during follow up
Intervention groups
1
Description
Control group: short term balloon inflation (10 second),once
Category
Other
2
Description
Intervention group: Inflate the balloon for 30 seconds.once
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomeini hospital complex
Full name of responsible person
Hamed Vahidi
Street address
The end of Keshavarz boulevard,Dr.Gharib St.
City
Tehran
Province
Tehran
Postal code
+981419733134
Phone
+98 21 6119 2648
Email
mahsabeyranvand169@gmail.com
2
Recruitment center
Name of recruitment center
Heshmat hospital
Full name of responsible person
Hamed Vahidi
Street address
Emam khomeini boulevard ,Pamchal,15 Khordad St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 5874
Email
mahsabeyranvand169@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Vahidi
Street address
Keshavarz boulevard ,Dr Gharib St.
City
Tehran
Province
Tehran
Postal code
+981419733134
Phone
+98 21 6119 2648
Email
mahsabeyranvand169@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Beyranvand Mahsa
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Emam Khomeini hospital complex, Dr Gharib ST.Keshavarz boulevard