Clinical Trials

CTEPH Predictors Following Acute Pulmonary Embolism

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05784896
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Assiut University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	CTEPH Predictors

Additional Details

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)