Effect of prophylactic intracoronary adenosine injection during percutaneous coronary intervention on Thrombolysis In Myocardial Infarction frame count in patients with non ST-elevation myocardial infarction
Evaluation the effect of prophylactic adenosine intracoronary injection in patients with non ST elevation myocardial infarction (NSTEMI) who underwent angioplasty on the incidence of slow or no reflow phenomenon and periprocedural Major adverse cardiac and cerebral events (MACCE)
Design
This is a phase 2, single center, open label, randomized control trial
Settings and conduct
This trial will be performed on patients with NSTMI and candidate for invasive strategy in the first 72 hours of the onset of symptom, the study steps will be as follow:
1. Patients transfer to catheterization laboratory.
2. Selective coronary angiography performs standard approach.
3. The characteristic of infarct related artery will be assessed and if suitable for stenting, the patients enrolled in the trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Chest pain or angina equivalent refer to myocardial ischemia
2.Past < 72 hours from symptoms onset
3. ST depression or T wave inversion in ECG or normal ECG
4. The patients candidate for PCI or coronary stenosis suitable for angioplasty
5.Elevated tropoin
Exclusion criteria:
1. History of asthma and chronic obstructive pulmonary disease
2.Life expectancy < 6 months
3.Cardiogenic shock ( sustain SBP < 90 mmHg)
4.Post coronary artery bypass surgery
5.Target vessel revascularization
6. left main lesion or severe three vessels disease
Intervention groups
intracoronary Adenosine as follow: 90 micrograms for left system in 10 cc or 60 micrograms for right system in 10 cc normal saline 0.9% - intracoronary 10 cc Normal saline 0.9% as a placebo.
Main outcome variables
The last Thrombolysis In Myocardial Infarction (TIMI) frame count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170619034621N2
Registration date:2020-02-01, 1398/11/12
Registration timing:registered_while_recruiting
Last update:2020-02-01, 1398/11/12
Update count:0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Azadeh Mozayani Monfared
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1731
Email address
a.mozayani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of prophylactic intracoronary adenosine injection during percutaneous coronary intervention on Thrombolysis In Myocardial Infarction frame count in patients with non ST-elevation myocardial infarction
Public title
Effect of prophylactic intracoronary adenosine injection in non ST-elevation myocardial infarction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
chest pain or equivalent angina refer to myocardial ischemia
past less than 72 hours from onset of symptoms
ECG with ST depression or T wave inversion or normal ECG
elevated troponin
the patients candidate for PCI and their coronary stenosis suitable for stenting
age more than 18 years
fill out an informed constant form
Exclusion criteria:
History of asthma and chronic obstructive pulmonary disease
Treatment with dipyridamole
life expectancy less than 6 months
Cardiogenic shock (sustain SBP<90 mmHg)
Post coronary artery bypass graft surgery
Atrioventricular block in first ECG
ST elevation myocardial infarction
History of renal failure ( exception patients underwent hemodialysis)
Need for Target vessel revascularization ( TVR )
The coronary artery stenosis will not be suitable for angioplasty
Left main lesion or severe 3 vessels disease
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
4-way block randomization method will be selected, which was performed with designed software system in cath lab, and after entering the patients file code , the group of patient will be identified.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rajaiee Heart Center
Street address
Hashemirafsanjani Highway
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2020-01-25, 1398/11/05
Ethics committee reference number
IR.RHC.REC.1398.073
Health conditions studied
1
Description of health condition studied
Non ST elevation myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
No/slow flow phenomenon
Timepoint
immediately at the end of the procedure
Method of measurement
TIMI frame count in angiography
Secondary outcomes
1
Description
in hospital major adverse cardiac and cerebral events
Timepoint
during hospitalization
Method of measurement
monitoring
2
Description
period of hospitalization
Timepoint
during hospitalization
Method of measurement
measuring the number of day that patient which hospitalized
3
Description
lethal arrhythmia
Timepoint
during hospitalization
Method of measurement
cardiac monitoring
Intervention groups
1
Description
intervention group: Adenosine will be used as the vasodilator drug in this group.It will be prescribed intracoronary via well engaged guiding catheter.The dose will be mentioned as follow: 90 micrograms for left system in 10 cc normal saline 0.9% 60 micrograms for right system in 10 cc normal saline 0.9%
Category
Prevention
2
Description
Control group: 10 cc Normal saline 0.9% will be used intracoronary via guiding catheters
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaiee Heart center
Full name of responsible person
Azadeh Mozayanimonfared
Street address
Hashemi Rafsanjani Hwy
City
Tehran
Province
Tehran
Postal code
19969 11151
Phone
+98 21 23921
Email
a.mozayani@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajaiee Heart Center
Full name of responsible person
Dr. Alireza Rashidinejad
Street address
Hashemi Rafsanjani Hwy
City
Tehran
Province
Tehran
Postal code
19969 11151
Phone
+98 21 23921
Email
alirezarashidinejad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rajaiee Heart Center
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
Shahid Rajaiee Heart Center
Full name of responsible person
Azadeh Mozayanimonfared
Position
Shahid Rajaiee Heart Center
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Hashemi Rafsanjani Hwy
City
Tehran
Province
Tehran
Postal code
19969 11151
Phone
+98 21 23921
Email
a.mozayani@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Rajaiee Heart Center
Full name of responsible person
Azadeh Mozayanimonfared
Position
Resident of interventional cardiology
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Hashemi Rafsanjani Hwy
City
Tehran
Province
Tehran
Postal code
19969 11151
Phone
+98 21 23921
Email
a.mozayani@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Rajaiee Heart Center
Full name of responsible person
Azadeh Mozayanimonfared
Position
Resident of interventional cardiology
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Hashemi Rafsanjani Hwy
City
Tehran
Province
Tehran
Postal code
19969 11151
Phone
+98 21 23921
Email
a.mozayani@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all collected deidentified IPD
When the data will become available and for how long
immediately after result publication
To whom data/document is available
all researcher
Under which criteria data/document could be used
no limitation
From where data/document is obtainable
a.mozayani@umsha .ac.ir
What processes are involved for a request to access data/document
after assessment in research committee during 1 month