Chronic Thromboembolic Pulmonary Hypertension After Pulmonary Embolism

Sponsor

Ester Ashraf Faried Beshay (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06081881

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

to detect the incidence of CTEPH patients.

Primary outcome To predict CETHP in symptomatic patients after pulmonary embolism episode.

Secondary outcome:

On Echocardiography revealed RV dysfunction which are peak TR Velocity , the RV/LV basal diameter ratio, flattening of the IVS, RV acceleration time and/or midsystolic notching, IVC diameter with decreased inspiratory collapse and RA area.

Condition or Disease	Intervention/Treatment	Phase
Chronic Thromboembolic Pulmonary Hypertension

Detailed Description

Chronic thrombo embolic pulmonary hypertension(CTEPH)is a progressive pulmonary vascular disease characterized by chronic obstruction of major pulmonary arteries with flow-limiting organized thrombi. In the clinical classification of the 6thWorld Symposium on Pulmonary Hypertension, CTEPH/chronic thromboembolic pulmonary disease(CTED)are in group4, labeled as PH due to pulmonary artery obstruction. CTEPH should be considered in PE patients if:(1)they report symptoms that could be related to CTEPH or with frank right heart failure,(2)the CTPA used to diagnose acute PE shows signs indicative of CTEPH,(3)they have risk factors or predisposing conditions for CTEPH. Recurrent venous thromboembolism(VTE),post-thrombotic syndrome, bleeding ,and functional limitations as important outcome measures of acute PE treatment , Dyspnea ,anxiety, chest pain ,post-thrombotic panic syndrome, and depression that lead to persistent functional limitations and/or decreased quality of life have been labeled as post-PE syndrome(PPS),includes CTEPH. Early diagnosis of CTEPH is important ,as it is the only form of PH that is potentially curable , but also challenging because signs of right heart failure only become evident in advanced disease stages and earlier disease stages are characterized by non specific or even absence of symptoms. The diagnostic work up of suspected CTEPH ,starts with trans thoracic Doppler echocardiography, In addition to the peak tricuspid regurgitation velocity , the right ventricle/left ventricle basal diameter ratio, flattening of the interventricular septum, right ventricular acceleration time and/or mid systolic notching, inferior vena cava diameter with decreased inspiratory collapse and right atrial area are used echocardiographic signs to assess the probability of PH.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Predictors for Chronic Thromboembolic Pulmonary Hypertension After Pulmonary Embolism Episode

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2027

Anticipated Study Completion Date :

Jan 1, 2027

Outcome Measures

Primary Outcome Measures

Incidence of CETHP in symptomatic patients after pulmonary embolism episode. [3 years]
Incidence of CETHP in symptomatic patients after pulmonary embolism episode.

Secondary Outcome Measures

Measuring RV dysfunction by Echocardiography [3 years]
Measuring RV dysfunction by Echocardiography

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Any patient diagnosed as acute pulmonary embolism ,aged between 18-80 years old which Pulmonary Embolism Severity Index (PESI) class III-V or sPESI ≥1,

Exclusion Criteria:

any patient had secondary cause for pulmonary hypertension
any patient had chest disease
patients with severe kidney injury(eGFR>30 mg/dl/1.7m2)
patients have hepatic affection
any patient have contraindication to anti-coagulation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ester Ashraf Faried Beshay

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ester Ashraf Faried Beshay, resident, Assiut University

ClinicalTrials.gov Identifier:

NCT06081881

Other Study ID Numbers:

CTEPH after pulmonary embolism

First Posted:

Oct 13, 2023

Last Update Posted:

Oct 13, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ester Ashraf Faried Beshay, resident, Assiut University

CTEPH

Additional relevant MeSH terms:

Hypertension, Pulmonary

Pulmonary Embolism

Hypertension

Embolism

Study Results

No Results Posted as of Oct 13, 2023