Reversal of Complete Heart Block With Aminophylline in Inferior Wall Myocardial Infarction Patients

Phase 4

Not yet recruiting

• Conditions: Complete Heart Block; Inferior Wall Myocardial Infarction
• Interventions: Drug: Aminophylline Injection

• Registration Number: NCT05666219
• Lead Sponsor: National Institute of Cardiovascular Diseases, Pakistan

Brief Summary

In this study we will evaluate the rate of reversal of complete heart block with aminophylline in atropine resistant patients with inferior wall myocardial infarction (MI)

Detailed Description

Administration of Aminophylline can result in reversal of complete heart block in a significant number of atropine resistant patients with inferior wall MI. Hence, in this study our primary aim is to evaluate the rate of reversal of complete heart block with aminophylline in atropine resistant patients with inferior wall MI.

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-17
• Last Update Submitted: 2022-12-17
• Study Start: 2022-12-19
• Study First Posted: 2022-12-27
• Last Update Posted: 2022-12-27
• Primary Completion: 2023-06-18
• Study Completion: 2023-06-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Adult patients admitted with recent acute inferior wall myocardial infarction (MI)
• Hemodynamically stable blood pressure
• Complete heart block with Narrow QRS < 120 ms and ventricular rate >40/min persisting for at least 6 hours resistant to atropine
• Temporary pacemaker (TPM) already placed
• Patient asymptomatic with mean arterial pressure of greater than 65 mmHg with TPM rate placed at 40/min

Exclusion Criteria

• Patients with cardiogenic shock
• Patients with preexisting permanent pacemaker and Implantable Cardioverter Defibrillator (ICD).
• Patients with prior history of AV block
• Drugs with dromo-tropic effects (beta blocker, calcium channel blocker, inotropes)
• Known liver disease (cirrhosis, hepatitis)
• Hypothyroidism
• Unable to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Aminophylline Injection	Patients receiving Injection Aminophylline

Primary Outcome Measures

Name	Time	Method
Reversal of complete heart block	Within 1 hour of 2nd dose	Conversion to sinus rhythm with 1:1 conduction

Secondary Outcome Measures

Name	Time	Method
Improved conduction	Within 1 hour of 2nd dose	Combined end point of 1:1 conduction and improved conduction to second degree AV block
Major adverse cardiac events (MACE)	Within 12 hours	Ventricular arrhythmias ( VT more than 3 beats), decrease in ventricular escape rate requiring increasing pacing rate, cardiac arrest or death