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NCT04757129 Clinical Trial

Changes of Cardiopulmonary Function After Thrombolysis in Patients With Pulmonary Embolism

Acute Pulmonary Embolism Clinical Trial

— CCFATAPE  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04757129
Other study ID # JSSRMYY-HB-2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date September 30, 2024

Study information
Verified date May 2024
Source Nanjing Medical University
Contact Bin He, Master
Phone 13770789159
Email hbhbwywy34@sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

About 80-100 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 June 30, 2024. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date September 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
China the First Affiliated Hospital with Nanjing Medical University Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Bin He

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary cardiopulmonary function changes changes of PO2,SBP,HR, cardiac ultrasound index and vasoactive drug dosage 48 hours after thrombolysis
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