Detection of chronic thromboembolic pulmonary hypertension (CTEPH) following pulmonary embolism
| ISRCTN | ISRCTN61417303 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61417303 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/05/2009
- Registration date
- 29/06/2009
- Last edited
- 08/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr John-David Aubert
Scientific
Scientific
University Hospital Lausanne
Rue du Bugnon
Lausanne
1011
Switzerland
Study information
| Study design | Prospective multicentre observational phase V study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Single-centre |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Multicentre observational screenINg survey for the detection of chronic thromboembolic PUlmonary hyperTensiON (CTEPH) following Pulmonary Embolism |
| Study acronym | INPUT ON PE |
| Study objectives | 1. To evaluate the incidence rate of symptomatic chronic thromboembolic pulmonary hypertension (CTEPH) following pulmonary embolism (PE) 2. To identify and evaluate potential risk factors for developing CTEPH following PE 3. To test the usefulness of a screening algorithm based on dyspnoea in medical practice for diagnosing CTEPH after confirmed PE |
| Ethics approval(s) | Commission d'ethique de la recherche Lausanne approved on the 17th February 2009 (ref: 226/08) |
| Health condition(s) or problem(s) studied | Pulmonary embolism/chronic thromboembolic pulmonary hypertension |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Amount of patients who develop symptomatic CTEPH at 6, 12 and 24 months after PE. |
| Secondary outcome measures | 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 |
| Overall study start date | 18/05/2009 |
| Completion date | 01/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1000 |
| Total final enrolment | 508 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 18/05/2009 |
| Date of final enrolment | 01/04/2013 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
University Hospital Lausanne
Lausanne
1011
Switzerland
1011
Switzerland
Sponsor information
Swiss Society for Pulmonary Hypertension (Switzerland)
Research organisation
Research organisation
c/o IMK Institut für Medizin und Kommunikation AG
Münsterberg 1
Basel
4001
Switzerland
| Website | http://www.sgph.ch/WebHome |
|---|---|
"ROR" |
https://ror.org/05yp06a73 |
Funders
Funder type
Research organisation
Swiss Society for Pulmonary Hypertension (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/04/2018 | 08/05/2019 | Yes | No |
Editorial Notes
08/05/2019: Total final enrolment and publication reference were added.
