CTEPH Predictors Following Acute Pulmonary Embolism

March 14, 2023 updated by: Asmaa Gamal Abd Elhamied, Assiut University

Predictors Of Chronic Thromboembolic Pulmonary Hypertension Following Acute Pulmonary Embolism

Identify risk factors for developing chronic thromboembolic pulmonary hypertension after acute pulmonary embolism.

Determine echocardiographic predictors of chronic thromboembolic pulmonary hypertension.

Determine the radiological predictors of chronic thromboembolic pulmonary hypertension in CT pulmonary angiography.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Chronic thromboembolic pulmonary hypertension(CTEPH) is considered to be a long-term complication after acute pulmonary embolism (PE) characterized by persistent perfusion defects of pulmonary arteries caused by fibrotic remodeling. Its pathophysiology has not been fully elucidated yet, although it has been accepted that the increased pulmonary vascular resistance is caused by obstruction of pulmonary arterial vessels by organized thromboemboli and by vascular remodeling of small un obstructed vessels. (1) Although CTEPH had been thought to develop in relatively few patients post-pulmonary thromboembolism, the latest data suggest an unexpectedly high incidence of approximately 4%. (2) In addition, although there are well-defined risk factors for pulmonary thromboembolism, the risk factors for CTEPH have not yet been sufficiently defined. (3) For that reason, the determination of risk factors is of great importance for the early diagnosis of patients with CTEPH, with its high mortality and morbidity. The clinical presentation of CTEPH is characterized by non-specific symptoms and include exercise intolerance, dyspnea, fatigue, chest pain, and syncope (at exercise). These symptoms are also consistent with other more common cardiopulmonary conditions such as asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, coronary artery disease, cardiac arrhythmia or heart failure not caused by chronic pulmonary thrombi. (4) These non-specific symptoms are commonly reported by patients who suffered from an acute PE and therefore, the possibility of CTEPH can be frequently considered . The diagnostic management of CTEPH is complex. In many patients pulmonary perfusion scintigraphy, transthoracic echocardiography and conventional pulmonary angiography with determination of pulmonary hemodynamics need to be performed before the diagnosis of CTEPH can be refuted. (5)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

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 Contact

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Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients of both gender more than 18 yrs admitted at chest department and diagnosed by CT pulmonary angiography as acute pulmonary embolism during a period of one year will be recruited in the study.

Description

Inclusion Criteria:

All adult patients of both gender more than 18 yrs admitted at chest department and diagnosed by CT pulmonary angiography as acute pulmonary embolism during a period of one year will be recruited in the study.

About 80 patients as the average number of patients admitted per month is 7.

Exclusion Criteria:

Patients with congenital or acquired heart diseases. Patients with chronic chest diseases. Patients previously diagnosed chronic thromboembolic pulmonary hypertension by V/Q scan.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Identify risk factors for devolping chronic thromboembolic pulmonary hypertention after acute pulmonary embolism.
Time Frame: baseline
Follow up to patients with acute pulmonary embolism after 3 months with V/Q scanning and ECHO
baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTEPH predictors in acute PE

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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