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ISRCTN61417303

Detection of chronic thromboembolic pulmonary hypertension (CTEPH) following pulmonary embolism

Data source: WHO (Imported from 03.05.2024)
Changed: Jun 2, 2019, 2:00 AM
Disease category:

Health conditions (Data source: WHO)

Pulmonary embolism/chronic thromboembolic pulmonary hypertension
Circulatory System
Pulmonary embolism

Interventions (Data source: WHO)


Patients with confirmed pulmonary embolism are followed up by regular telephone contacts at 6, 12 and 24 months using a standardised dyspnoea questionnaire. If the questionnaire discovers previously unreported symptoms of dyspnoea, patients are invited to the centre for confirmation of dyspnoea and, if confirmed, an echocardiography will be performed.

In case of a suspicion of PH at echocardiography, right heart catheterisation is performed for the confirmation of PH. CTEPH is confirmed if mean pulmonary arterial pressure (mPAP) greater than or equal to 25 mmHg, pulmonary capillary wedge pressure (PCWP) less than 15 mmHg and pulmonary vascular resistance (PVR) greater than or equal to 300 dyn*sec/cm^5 (3.75 Wood units), and additionally if V/Q scan shows a mismatch or imaging of the lung vessels show a pulmonary vessel obstruction. Any other causes of dyspnoea or elevated PH have to be excluded.

Inclusion/Exclusion Criteria (Data source: WHO)

Inclusion criteria:
Men and women (no age limitations) with pulmonary embolism within the preceding 4 weeks, demonstrated by:
1. Pulmonary angiography, or
2. Contrast enhanced spiral computed tomography, or
3. High probability lung scintigraphy (perfusion and ventilation imaging)

Exclusion criteria:
1. Confirmed diagnosis of pulmonary arterial hypertension (PAH) or CTEPH before inclusion
2. Pre-existing severe chronic dyspnoea (New York Heart Association [NYHA] grade III or IV) due to other reasons than PE
3. Cancer or other life-threatening disease with a life expectancy less than 6 months

Further information on the trial in WHO primary registry

http://isrctn.com/ISRCTN61417303

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN61417303
Further information on trial

Date trial registered

Jun 29, 2009

Incorporation of the first participant

May 18, 2009

Recruitment status

Completed

Academic title (Data source: WHO)

Multicentre observational screenINg survey for the detection of chronic thromboembolic PUlmonary hyperTensiON (CTEPH) following Pulmonary Embolism

Type of trial (Data source: WHO)

Observational

Design of the trial (Data source: WHO)

Prospective multicentre observational phase V study (Screening)

Phase (Data source: WHO)

Not Applicable

Primary end point (Data source: WHO)

Amount of patients who develop symptomatic CTEPH at 6, 12 and 24 months after PE.

Secundary end point (Data source: WHO)

1. Comparison of collected baseline data of the patients who developed CTEPH with the baseline data of the patients who did not develop CTEPH within the 2-year period after diagnosis of PE to identify any potential risk factors
2. Comparison of the results of the dyspnoea questionnaire answered by telephone with the dyspnoea evaluation by the investigator at the clinic to test the usefulness of the telephone screening algorithm in medical practice for diagnosing CTEPH after PE

Contact information (Data source: WHO)

Swiss Society for Pulmonary Hypertension (Switzerland)

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Contact for scientific information (Data source: WHO)

John-David
Aubert
University Hospital Lausanne Rue du Bugnon

Further trial identification numbers

Secondary ID (Data source: WHO)

N/A
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