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

Sponsor
National Institute of Cardiovascular Diseases, Karachi (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05666219
Collaborator
(none)
73
Enrollment
1
Arm
5.9
Anticipated Duration (Months)

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Drug: Aminophylline Injection
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
73 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
An Open Label Non-randomized Clinical TrialAn Open Label Non-randomized Clinical Trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 19, 2022
Anticipated Primary Completion Date :
Jun 18, 2023
Anticipated Study Completion Date :
Jun 18, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

Patients receiving Injection Aminophylline

Drug: 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.
Other Names:
  • Theophylline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reversal of complete heart block [Within 1 hour of 2nd dose]

      Conversion to sinus rhythm with 1:1 conduction

    Secondary Outcome Measures

    1. Improved conduction [Within 1 hour of 2nd dose]

      Combined end point of 1:1 conduction and improved conduction to second degree AV block

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Institute of Cardiovascular Diseases, Karachi

    Investigators

    • Study Chair: Azam Shafquat, MD, National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute of Cardiovascular Diseases, Karachi
    ClinicalTrials.gov Identifier:
    NCT05666219
    Other Study ID Numbers:
    • ERC-32/2022
    First Posted:
    Dec 27, 2022
    Last Update Posted:
    Dec 27, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Myocardial Infarction
    Heart Block
    Inferior Wall Myocardial Infarction
    Infarction
    Aminophylline
    Theophylline

    Study Results

    No Results Posted as of Dec 27, 2022