Acute Pulmonary EmbolismCCFATAPENCT04757129
Changes of Cardiopulmonary Function After Thrombolysis in Patients With Pulmonary Embolism
An observational study of Acute Pulmonary Embolism, run by Bin He at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pulmonary Embolism
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: medium-high risk or high risk pulmonary embolism and treated with thrombolysis
Who may be able to join
- medium-high risk or high risk pulmonary embolism and treated with thrombolysis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Bin He, Master, 13770789159, hbhbwywy34@sina.com
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Acute Pulmonary Embolism
- Keywords
- acute pulmonary embolism, thrombolysis, Alteplase, cardiopulmonary function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
cardiopulmonary function changes
changes of PO2，SBP，HR, cardiac ultrasound index and vasoactive drug dosage
Measured: 48 hours after thrombolysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Jan 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bin He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bin He, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757129
- Sponsor's protocol ID
- JSSRMYY-HB-2
- Acronym
- CCFATAPE
- Status last verified
- May 2024
- First submitted
- 29 Jan 2021
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes of Circulatory and Respiratory Function After Thrombolysis in Patients With Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT04757129
- Acronym / sponsor ID
- CCFATAPE / JSSRMYY-HB-2
- Conditions
- Acute Pulmonary Embolism
- Keywords
- acute pulmonary embolism, thrombolysis, Alteplase, cardiopulmonary function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bin HeUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- medium-high risk or high risk pulmonary embolism and treated with thrombolysis
Key inclusion criteria (1 listed)
- medium-high risk or high risk pulmonary embolism and treated with thrombolysis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cardiopulmonary function changes
Time frame: 48 hours after thrombolysis
changes of PO2，SBP，HR, cardiac ultrasound index and vasoactive drug dosage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pulmonary Embolism, run by Bin He at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin He, Master (13770789159, hbhbwywy34@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiopulmonary function changes (time frame: 48 hours after thrombolysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.