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

NCT ID: NCT05666219

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-19

Study Completion Date

2025-01-17

Brief Summary

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

Detailed Description

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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.

Conditions

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Complete Heart Block Inferior Wall Myocardial Infarction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

An Open Label Non-randomized Clinical Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

Patients receiving Injection Aminophylline

Group Type EXPERIMENTAL

Aminophylline Injection

Intervention Type DRUG

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.

Interventions

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Aminophylline Injection

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.

Intervention Type DRUG

Other Intervention Names

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Theophylline

Eligibility Criteria

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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 a 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 a prior history of AV block
* Drugs with dromotropic effects (beta blocker, calcium channel blocker, inotropes)
* Known liver disease (cirrhosis, hepatitis)
* Hypothyroidism
* Unable to consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Cardiovascular Diseases, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Azam Shafquat, MD

Role: STUDY_CHAIR

National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan

Other Identifiers

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ERC-32/2022

Identifier Type: -

Identifier Source: org_study_id

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