Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism (ELOPE)
24. november 2014 opdateret af: Dr. Susan Kahn, Sir Mortimer B. Davis - Jewish General Hospital
The ELOPE Study: Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism
The purpose of this study is to evaluate the long-term impact of Pulmonary Embolism (PE) on heart and lung function, quality of life, ability to work, symptoms of breathlessness and functional status of patients one year after their initial diagnosis and treatment for PE
Studieoversigt
Status
Ukendt
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
150
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
- QEII Health Sciences Centre
-
-
Ontario
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Ottawa, Ontario, Canada, K1Y 4E9
- The Ottawa Hospital
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Toronto, Ontario, Canada, M5G 2N2
- Toronto General Hospital
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Sir Mortimer B. Davis - Jewish General Hospital
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Montreal, Quebec, Canada, H3T 1M5
- St. Mary's Hospital Center
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients seen in the Emergency Department, in-patient wards, out-patient clinics or anticoagulation clinics.
Beskrivelse
Inclusion Criteria:
- First episode of acute symptomatic PE that was objectively diagnosed* within last 10 days
- Treated with anticoagulants
≥ 18 years old
- PE will be diagnosed if there is a high probability V/Q scan (as per PIOPED Study criteria 66), an intraluminal filling defect in segmental or larger vessels on CTPA or a constant intraluminal filling defect or abrupt cut-off of vessels greater than 2.5 mm diameter on pulmonary angiography 8,10. Patients with non-definitive test results (e.g. low or intermediate probability V/Q scan, subsegmental PE on CTPA (~5% of PE patients 12) will not be included in order to have a strictly defined population of patients with definite PE.
Exclusion Criteria:
- Contraindication or unable to perform CPET or 6MWT (amputated or paralyzed limb(s), severe lower extremity arthritis, preexisting cardiopulmonary condition precluding exercise including unstable angina or myocardial infarction in last 6 weeks, uncontrolled hypertension, serious cardiac dysrhythmia on resting EKG [severe bradycardia or tachycardia, sick sinus syndrome or multifocal premature ventricular contractions] and syncope)
- Contraindication to CTPA (allergy to iodinated contrast, CrCl or eGFR < 30 ml/min)
- Severe comorbidity (congestive heart failure [LVEF < 35%], severe COPD or restrictive lung disease [FEV1<50%, chronic need for oxygen therapy])
- Previous DVT (as ~40% of patients with proximal DVT have asymptomatic PE on lung imaging 67)
- Life expectancy < 1 year (e.g. active or terminal cancer, end-stage cardiac or respiratory disease).
- Pregnancy or lactation
- Unable to read questionnaire in English or French
- Unable to return to study centre for required follow-up visits
- Unable or unwilling to provide written informed consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Exercise Limitation
Tidsramme: 1 month
|
Exercise limitation will be assessed by VO2 max (% predicted) on cardiopulmonary exercise testing (CPET)
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1 month
|
|
Exercise Limitation
Tidsramme: 12 months
|
Exercise limitation will be assessed by VO2 max (% predicted) on cardiopulmonary exercise testing (CPET)
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of Life
Tidsramme: Baseline
|
Quality of Life will be assessed using the SF-36v2 questionnaire.
|
Baseline
|
|
Quality of Life
Tidsramme: 1 month
|
Quality of Life will be assessed using the SF-36v2 questionnaire.
|
1 month
|
|
Quality of Life
Tidsramme: 3 months
|
Quality of Life will be assessed using the SF-36v2 questionnaire.
|
3 months
|
|
Quality of Life
Tidsramme: 6 months
|
Quality of Life will be assessed using the SF-36v2 questionnaire.
|
6 months
|
|
Quality of Life
Tidsramme: 12 months
|
Quality of Life will be assessed using the SF-36v2 questionnaire.
|
12 months
|
|
Respiratory Disease-Specific Measures
Tidsramme: Baseline
|
Respiratory Disease-Specific measures will be assessed using the Pulmonary Embolism Quality of Life Questionnaire (PEmb-QOL) and the San Diego Shortness of Breath Questionnaire (SOBQ).
|
Baseline
|
|
Respiratory Disease-Specific Measures
Tidsramme: 1 month
|
Respiratory Disease-Specific measures will be assessed using the Pulmonary Embolism Quality of Life Questionnaire (PEmb-QOL) and the San Diego Shortness of Breath Questionnaire (SOBQ).
|
1 month
|
|
Respiratory Disease-Specific Measures
Tidsramme: 3 months
|
Respiratory Disease-Specific measures will be assessed using the Pulmonary Embolism Quality of Life Questionnaire (PEmb-QOL) and the San Diego Shortness of Breath Questionnaire (SOBQ).
|
3 months
|
|
Respiratory Disease-Specific Measures
Tidsramme: 6 months
|
Respiratory Disease-Specific measures will be assessed using the Pulmonary Embolism Quality of Life Questionnaire (PEmb-QOL) and the San Diego Shortness of Breath Questionnaire (SOBQ).
|
6 months
|
|
Respiratory Disease-Specific Measures
Tidsramme: 12 months
|
Respiratory Disease-Specific measures will be assessed using the Pulmonary Embolism Quality of Life Questionnaire (PEmb-QOL) and the San Diego Shortness of Breath Questionnaire (SOBQ).
|
12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Susan R Kahn, M.D., M.Sc., Sir Mortimer B. Davis - Jewish General Hospital
- Ledende efterforsker: Andrew Hirsch, M.D., Sir Mortimer B. Davis - Jewish General Hospital
- Ledende efterforsker: John Granton, M.D., University of Toronto
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Kahn SR, Hirsch AM, Akaberi A, Hernandez P, Anderson DR, Wells PS, Rodger MA, Solymoss S, Kovacs MJ, Rudski L, Shimony A, Dennie C, Rush C, Geerts WH, Aaron SD, Granton JT. Functional and Exercise Limitations After a First Episode of Pulmonary Embolism: Results of the ELOPE Prospective Cohort Study. Chest. 2017 May;151(5):1058-1068. doi: 10.1016/j.chest.2016.11.030. Epub 2016 Dec 6.
- Kahn SR, Houweling AH, Granton J, Rudski L, Dennie C, Hirsch A. Long-term outcomes after pulmonary embolism: current knowledge and future research. Blood Coagul Fibrinolysis. 2014 Jul;25(5):407-15. doi: 10.1097/MBC.0000000000000070.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2010
Primær færdiggørelse (Forventet)
1. december 2014
Studieafslutning (Forventet)
1. februar 2015
Datoer for studieregistrering
Først indsendt
28. juli 2010
Først indsendt, der opfyldte QC-kriterier
2. august 2010
Først opslået (Skøn)
3. august 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. november 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. november 2014
Sidst verificeret
1. november 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MOP-93627
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .