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ISRCTN61417303

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

Datenbasis: WHO (Import vom 22.09.2019)
Geändert: 02.06.2019
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Pulmonary embolism/chronic thromboembolic pulmonary hypertension
Circulatory System
Pulmonary embolism

Interventions (Datenquelle: 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 (Datenquelle: 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

Weitere Angaben zur Studie im WHO-Primärregister

http://isrctn.com/ISRCTN61417303

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN61417303

Weitere Informationen zur Studie

Registrationsdatum der Studie

29.06.2009

Einschluss der ersten teilnehmenden Person

18.05.2009

Rekrutierungsstatus

Completed

Wissenschaftlicher Titel (Datenquelle: WHO)

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

Studientyp (Datenquelle: WHO)

Observational

Design der Studie (Datenquelle: WHO)

Prospective multicentre observational phase V study (Screening)

Phase (Datenquelle: WHO)

Not Applicable

Primäre Endpunkte (Datenquelle: WHO)

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

Sekundäre Endpunkte (Datenquelle: 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

Kontakt für Auskünfte (Datenquelle: WHO)

Swiss Society for Pulmonary Hypertension (Switzerland)

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Switzerland

Kontakt für weitere Auskünfte zur Studie

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

John-David
Aubert
University Hospital Lausanne Rue du Bugnon

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

Swiss Society for Pulmonary Hypertension (Switzerland)

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

N/A