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CCFATAPE: Changes of Cardiopulmonary Function After Thrombolysis in Patients With Pulmonary Embolism

Sponsor
Bin He (Other)
Overall Status
Recruiting
CT.gov ID
NCT04757129
Collaborator
(none)
50
Enrollment
1
Location
26.9
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators expect to enroll 50 acute pulmonary embolism patients treated with thrombolysis in two hospitals. Dynamic changes of cardiopulmonary function after thrombolysis are detected to evaluate which indicators can quickly reflect the effectiveness of thrombolysis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    About 50 acute pulmonary embolism(APE) patients treated with thrombolysis are enrolled in the First Affiliated Hospital with Nanjing Medical University and Nanjing Drum Town Hospital from January 1, 2020, to December 31, 2021. According to the 2019 ESC guideline, the standards for thrombolysis in APE patients are as follows: within 2 weeks of onset; high-risk pulmonary embolism; medium-high-risk pulmonary embolism with symptoms of aggravation.

    Investigators dynamically monitor cardiopulmonary function of participants after thrombolysis, including blood pressure, heart rate, respiratory rate, blood gas analysis, 2-dimensional echocardiography (left and right ventricular diameter, pulmonary artery pressure, interventricular septum) and laboratory tests (cTnT,pro-BNP).participants are divided into two groups: thrombolytic success group and thrombolytic failure group according the previously reported criterion which is evaluated 48h after thrombolysis.

    Cardiopulmonary characteristics are analyzed to seek accurate and rapid index to reflect success of thrombolysis.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Dynamic Changes of Circulatory and Respiratory Function After Thrombolysis in Patients With Acute Pulmonary Embolism
    Actual Study Start Date :
    Jan 1, 2020
    Anticipated Primary Completion Date :
    Dec 30, 2021
    Anticipated Study Completion Date :
    Mar 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    thrombolysis success group

    Echocardiography was performed 48 hours after thrombolysis to evaluate the success of thrombolysis according to previous report.
    thrombolysis failure group

    Echocardiography was performed 48 hours after thrombolysis to evaluate the success of thrombolysis according to previous report.

    Outcome Measures

    Primary Outcome Measures

    1. cardiopulmonary function changes [48 hours after thrombolysis]

      changes of PO2，SBP，HR, cardiac ultrasound index and vasoactive drug dosage

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • medium-high risk or high risk pulmonary embolism and treated with thrombolysis
    Exclusion Criteria:

    • lack of radiologic evidence to diagnose APE

    • death within 48 hours after thrombolytic therapy

    • unable to partner treatment and leaving hospitals

    • missing other necessary data

    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 the First Affiliated Hospital with Nanjing Medical University Nanjing Jiangsu China 210029

    Sponsors and Collaborators

    • Bin He

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bin He, Attending physician of Affiliated Hospital of Nanjing Medical University, Nanjing Medical University
    ClinicalTrials.gov Identifier:
    NCT04757129
    Other Study ID Numbers:
    • JSSRMYY-HB-2
    First Posted:
    Feb 17, 2021
    Last Update Posted:
    Feb 17, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bin He, Attending physician of Affiliated Hospital of Nanjing Medical University, Nanjing Medical University
    acute pulmonary embolism
    thrombolysis
    Alteplase
    cardiopulmonary function
    Additional relevant MeSH terms:
    Pulmonary Embolism
    Embolism

    Study Results

    No Results Posted as of Feb 17, 2021