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

Study Overview
=================
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.

Official Title
-----------------
Assessing the Impact of Aminophylline in the Reversal of Complete Heart Block Secondary to Inferior Wall MI in Atropine Resistant Patients: An Open Label Non-randomized Clinical Trial

Conditions
-----------------
Complete Heart Block, Inferior Wall Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Aminophylline Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: An Open Label Non-randomized Clinical Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Patients receiving Injection Aminophylline | Drug: Aminophylline Injection<br>* Injection Aminophylline IV 240 mg will be given over 10 minutes. After 1 hour, Aminophylline 240 mg second dose will be given over 10 minutes.<br>* Other names: Theophylline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reversal of complete heart block | Conversion to sinus rhythm with 1:1 conduction | Within 1 hour of 2nd dose | 

Secondary Outcome Measures

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