Effect of intracoronary adenosine injection before stenting in emergency primary percutaneous coronary intervention for preventing no-reflow phenomenon in patients with ST elevation myocardial infarction
To determine the effect of intracoronary adenosine injection before stenting in emergency primary percutaneous coronary intervention for preventing no-reflow phenomenon in patients with ST-elevation myocardial infarction
Design
The patients were randomized into intervention and the control group. The intervention group received intracoronary adenosine and the control group received no drug or placebo.
Settings and conduct
Recruitment will be done in the emergency department of Imam Khomeini Hospital and the other steps of the study will be done in the catheterization laboratory of Imam Khomeini Hospital. None of the patients were aware of the allocated group.
Participants/Inclusion and exclusion criteria
Patients with acute STEMI who presented to the emergency department of Imam Khomeini Hospital (Tehran, Iran) and underwent primary PCI were enrolled. The inclusion criteria were the diagnosis of STEMI at the emergency department, having full criteria for primary PCI, TIMI flow grade = 0-1 in the coronary angiography, and giving consent to take part in our study. The exclusion criteria were a cardiogenic shock, complete AV block, severe renal failure (serum creatinine > 3 mg/dl) and need for emergent coronary bypass graft surgery.
Intervention groups
The intervention group received intracoronary adenosine (200 mcg bolus for right side coronary arteries and 400 mcg bolus for the left side coronary arteries) through the guiding catheter before stenting.
Main outcome variables
The primary end-point of the study was the occurrence of the no-reflow phenomenon that was defined as:
TIMI flow grade<3
Myocardial blush grade<=2
TIMI frame count <36 for left ascending coronary artery, <22 for the left circumflex artery and <20 for the right coronary artery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120516009768N6
Registration date:2019-07-21, 1398/04/30
Registration timing:retrospective
Last update:2019-07-21, 1398/04/30
Update count:0
Registration date
2019-07-21, 1398/04/30
Registrant information
Name
Akbar Shafiee
Name of organization / entity
Tehran Heart Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9256
Email address
shafiee@leydenacademy.nl
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
2019-03-03, 1397/12/12
Actual recruitment end date
2019-03-21, 1398/01/01
Trial completion date
2019-09-01, 1398/06/10
Scientific title
Effect of intracoronary adenosine injection before stenting in emergency primary percutaneous coronary intervention for preventing no-reflow phenomenon in patients with ST elevation myocardial infarction
Public title
Effect of intracoronary adenosine injection before stenting in emergency primary percutaneous coronary intervention for preventing no-reflow phenomenon in patients with ST elevation myocardial infarction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of ST-elevation myocardial infarction based on electrocardiogram and laboratory test
Consent for taking part in the study
TIMI flow frade=0-1 in the coronary angiography
Having the criteria for primary percutaneous coronary intervention
Exclusion criteria:
Cardiogenic shock
Complete AV block
Chronic Renal Failure (Serum creatinine >3 mg/dl)
Need for emergency coronary artery bypass graft surgery
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
220
Actual sample size reached:
228
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed using an internet-based software that did simple randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were unaware of their study group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Imam Khomeini Hospital
Street address
Gharib St
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.TUMS.IKHC.REC.1397.349
Health conditions studied
1
Description of health condition studied
ST segment elevation myocardial infarction
ICD-10 code
I21.3
ICD-10 code description
ST elevation (STEMI) myocardial infarction of unspecified site
Primary outcomes
1
Description
No reflow phenomenon is the failure of blood to reperfuse an ischemic area after revascularization
Timepoint
After stenting
Method of measurement
Based on the angiographic tools: TIMI flow grade, TIMI frame count & Myocardial blush grade
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: ٌWill receive intracoronary adenosine infusion (200 mcg bolus for right-side coronary arteries and 400 mcg bolus for the left-side coronary arteries) through the guiding catheter before stenting.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive no intervention and will receive routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohammad Sadeghian
Street address
Imam Khoemini Hospital, Dr. Gharib st, Keshavarz Blvd