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

April 6, 2024 updated by: Bin He

Dynamic Changes of Circulatory and Respiratory Function After Thrombolysis in Patients With Acute Pulmonary Embolism

The investigators expect to enroll about 80-100 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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital with Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

medium-high risk or high risk pulmonary embolism and treated with thrombolysis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiopulmonary function changes
Time Frame: 48 hours after thrombolysis
changes of PO2，SBP，HR, cardiac ultrasound index and vasoactive drug dosage
48 hours after thrombolysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bin He

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

February 14, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 6, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSSRMYY-HB-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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