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

Primary Purpose

Complete Heart Block, Inferior Wall Myocardial Infarction

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Aminophylline Injection
Sponsored by
National Institute of Cardiovascular Diseases, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complete Heart Block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment group

    Arm Description

    Patients receiving Injection Aminophylline

    Outcomes

    Primary Outcome Measures

    Reversal of complete heart block
    Conversion to sinus rhythm with 1:1 conduction

    Secondary Outcome Measures

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

    Full Information

    First Posted
    December 13, 2022
    Last Updated
    December 17, 2022
    Sponsor
    National Institute of Cardiovascular Diseases, Pakistan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05666219
    Brief Title
    Reversal of Complete Heart Block With Aminophylline in Inferior Wall Myocardial Infarction Patients
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 19, 2022 (Anticipated)
    Primary Completion Date
    June 18, 2023 (Anticipated)
    Study Completion Date
    June 18, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Institute of Cardiovascular Diseases, Pakistan

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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)
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Complete Heart Block, Inferior Wall Myocardial Infarction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Model Description
    An Open Label Non-randomized Clinical Trial
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    73 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment group
    Arm Type
    Experimental
    Arm Description
    Patients receiving Injection Aminophylline
    Intervention Type
    Drug
    Intervention Name(s)
    Aminophylline Injection
    Other Intervention Name(s)
    Theophylline
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Reversal of complete heart block
    Description
    Conversion to sinus rhythm with 1:1 conduction
    Time Frame
    Within 1 hour of 2nd dose
    Secondary Outcome Measure Information:
    Title
    Improved conduction
    Description
    Combined end point of 1:1 conduction and improved conduction to second degree AV block
    Time Frame
    Within 1 hour of 2nd dose
    Title
    Major adverse cardiac events (MACE)
    Description
    Ventricular arrhythmias ( VT more than 3 beats), decrease in ventricular escape rate requiring increasing pacing rate, cardiac arrest or death
    Time Frame
    Within 12 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Deebaj Nadeem, FCPS
    Phone
    +923360833853
    Email
    deeb2512@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Azam Shafquat, MD
    Phone
    +923002016980
    Email
    azamshafquat@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Azam Shafquat, MD
    Organizational Affiliation
    National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No individual participant data sharing plan in placed

    Learn more about this trial

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

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