Intravenous Atropine in Reducing Reperfusion Arrhythmias, Conduction Abnormalities and Hypotension in Inferior ST-elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 4
Contacts and Locations
Study Contact
Study Contact
- Name: Mohamed G Elewa, MD
- Phone Number: +201019811895
- Email: mdgamal92@gmail.com
Study Locations
-
-
Abbasia
-
Cairo, Abbasia, Egypt
- Ain Shams University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Acute inferior ST elevation myocardial infarction
Exclusion Criteria:
- Execution of rescur percutaneous coronary intervention after thrombolysis
- Mechanical complications or no reflow or spontaneous reperfusion.
- Prior implantation of permanent or temporary pacemakers
- History of bradycardia, hypotension or ventricular tachycardia with a definitive cause (unrelated to the disease under study)
- Prior coronary artery bypass graft surgery
- Atropine contraindications Unwillingness to participate in the
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Atropine arm
This group will receive intravenous atropine 1 mg immediately before wire crossing
|
Intravenous atropine 1 mg immediately before wire crossing during primary percutaneous coronary intervention
|
|
Placebo Comparator: Placebo arm
This group will receive intravenous normal saline immediately before wire crossing
|
Intravenous normal saline as placebo immediately before wire crossing during primary percutaneous coronary intervention
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Conduction abnormalities
Time Frame: Periprocedurally
|
Occurrence of conduction abnormalities
|
Periprocedurally
|
|
Reperfusion arrhythmias
Time Frame: Periprocedurally
|
Occurrence of reperfusion arrhythmias
|
Periprocedurally
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Major adverse cardiac events
Time Frame: Periprocedurally
|
Inhospital major adverse cardiac events including all-cause mortality, cardiovascular mortality, stroke and myocardial infarction
|
Periprocedurally
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- FMASU R49/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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