Chronic Thromboembolic Pulmonary Hypertension After Pulmonary Embolism

Predictors for Chronic Thromboembolic Pulmonary Hypertension After Pulmonary Embolism Episode

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.

Study Overview

• Status: Not yet recruiting
• Conditions: 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 Type: Observational
• Enrollment (Estimated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients underwent pulmonary embolism episodes

Description

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:

Secondary causes for pulmonary hypertension Severe kidney injury(eGFR>30 mg/dl/1.7m2) Hepatic affection Contraindication to anti-coagulation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of CTEHP in symptomatic patients after pulmonary embolism episode.	Incidence of CTEHP in symptomatic patients after pulmonary embolism episode.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of RV dysfunction by Echocardiography	Measure of RV dysfunction by Echocardiography	3 years

Collaborators and Investigators

• Sponsor: Ester Ashraf Faried Beshay

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: October 7, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: CTEPH
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Hypertension; Embolism; Hypertension, Pulmonary; Pulmonary Embolism
• Other Study ID Numbers: CTEPH after pulmonary embolism

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No