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

• Register: ISRCTN
• Last refreshed on: 27 May 2019
• Main ID: ISRCTN61417303
• Date of registration: 29/06/2009
• Prospective Registration: No
• Primary sponsor: Swiss Society for Pulmonary Hypertension (Switzerland)
• Public title: Detection of chronic thromboembolic pulmonary hypertension (CTEPH) following pulmonary embolism
• Scientific title: Multicentre observational screenINg survey for the detection of chronic thromboembolic PUlmonary hyperTensiON (CTEPH) following Pulmonary Embolism
• Date of first enrolment: 18/05/2009
• Target sample size: 1000
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN61417303
• Study type: Observational
• Study design: Prospective multicentre observational phase V study (Screening)
• Phase: Not Applicable

Countries of recruitment

Switzerland

Contacts

• Name: John-David Aubert

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Pulmonary embolism/chronic thromboembolic pulmonary hypertension
Circulatory System
Pulmonary embolism

Intervention(s)

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

Swiss Society for Pulmonary Hypertension (Switzerland)

Ethics review

Status:
Approval date:
Contact:

Commission d'ethique de la recherche Lausanne approved on the 17th February 2009 (ref: 226/08)

Results

• Results available: Yes
• Date Completed: 01/04/2013