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OPTimal IMAging strategy in patients suspected of non-traumatic Pulmonary disease at the ED: Chest X-ray or CT The OPTIMACT trial


- candidate number25629
- NTR NumberNTR6163
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-dec-2016
- Secondary IDsNL57923.018.16 METC AMC
- Public TitleOPTimal IMAging strategy in patients suspected of non-traumatic Pulmonary disease at the ED: Chest X-ray or CT The OPTIMACT trial
- Scientific TitleOPTimal IMAging strategy in patients suspected of non-traumatic Pulmonary disease at the ED: Chest X-ray or CT The OPTIMACT trial
- ACRONYMOPTIMACT
- hypothesisPrimary Objective:
To evaluate whether the replacement of chest X-ray by ultra-low-dose chest CT (ULD chest CT) in the diagnostic work-up of patients suspected of non-traumatic pulmonary disease at the Emergency Department leads to more accurate diagnoses and more timely treatment, resulting in increasing efficiency, lower costs while maintaining health related quality of life.
- Healt Condition(s) or Problem(s) studiedCough, Chest pain, Dyspnea
- Inclusion criteria> 18 years,
presenting at the Emergency Department with a suspicion of non-traumatic pulmonary disease: complaints of: dyspnoea, fever, chest pain or cough.
written informed consent for participation in study and using individual patient data for study purposes.
- Exclusion criteriaincapacitated patients,
pregnant patients,
life expectancy less than one month,
patients with anticipated barriers to completing follow-up data collection,
patients who are not able to undergo a chest X-ray or ULD chest CT,
earlier participation in this RCT.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 2-jan-2017
- planned closingdate
- Target number of participants1500
- Interventionsobservational study
- Primary outcomePrimary outcome is a correct diagnosis at Emergency Department discharge (including use of other diagnostic measures if indicated), as confirmed by an independent adjudication committee at day 28.
- Secondary outcomeSecondary study parameters are time to preliminary imaging result, length of stay at Emergency Department, length of hospital stay, mortality within 28 days, quality of life (SF-12 / SF-6D / EQ5D) at 28 days, direct healthcare costs after 28 days, economic impact after 28 days (iPCQ / iMCQ), number of patients in follow-up because of incidental findings on chest X-ray or ULD chest CT.
- TimepointsAssessments at baseline and at day 28
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. I.A.H. van den Berk
- CONTACT for SCIENTIFIC QUERIESDrs. I.A.H. van den Berk
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summaryBackground of the study:
Chest X-ray has been the standard imaging method for patients suspected of non-traumatic pulmonary disease in the Emergency department for years. Recently, ultra-low-dose chest computed tomography (ULD chest CT) has been introduced that provides substantially more detailed information on pulmonary conditions that may cause pulmonary complaints, with a dose in the order of the chest X-ray (0.1 mSv vs 0.05mSv). This ULD chest CT most likely will lead to more timely diagnoses and improved patient management. Therefore replacement of chest X-ray by ULD chest CT seems a logical step. However, this assumption of more timely diagnoses and improved patient management has not been substantiated. Further, the use of CT leads to higher direct costs and its availability is limited. Importantly, incidental findings on CT lead to additional examinations and associated costs and burden while these findings will be beneficial in only a minority of patients. Therefore it is necessary to compare both strategies to determine whether it is effective to replace the current diagnostic strategy with chest X-ray for ULD chest CT in patients suspected of non traumatic pulmonary disease at the Emergency department.
Objective of the study:
Primary objective To evaluate the effects, in terms of patient-related health outcomes and costs, of replacing chest X-ray by ULD chest CT in the diagnostic work-up of patients suspected of non-traumatic pulmonary disease at the ED. Secondary objective To evaluatie wether the replacement of chest X-ray by ultra-low-dose chest CT (ULD chest CT) in the diagnostic work-up of patients suspected of non-traumatic pulmonary disease at the Emergency Department leads to more accurate diagnoses and more timely treatment. To evaluate, for patients with clinically suspected community-acquired pneumonia (CAP), - the diagnostic accuracy and clinical impact of performing ultra-low-dose plain chest CT as compared to conventional chest X-ray. - the accuracy of CT versus conventional X-ray to predict the etiology of the pneumonia. - the value of new and previously described (molecular) biomarkers for the diagnosis ande etiology of CAP
Study design:
A multi-centre, pragmatic, randomized trial comparing chest X-ray to ULD chest CT in patients suspected of non-traumatic pulmonary disease presenting at the Emergency department. As both imaging modalities are considered state-of-the-art, with a radiation dose that is comparable, strategies will rotate randomly per calendar month. Before imaging informed consent will be obtained for participation in the study ans using individual patient data for study purposes. Embedded in the study is a sub-study for patients suspected of community-acquired pneumonia.
Study population:
Consecutive adult patients presenting at the Emergency department suspected of non-traumatic pulmonary disease with complaints of dyspnoea, fever, chest pain or cough.
- Main changes (audit trail)13-okt-2017 -IK:

Primary outcome:
"Primary outcome is a correct diagnosis at Emergency Department discharge (including use of other diagnostic measures if indicated), as confirmed by an independent adjudication committee at day 28."

replaced by

"To evaluate the effects, in terms of patient-related health outcomes and costs, of replacing chest X-ray by ULD chest CT in the diagnostic work-up of patients suspected of non-traumatic pulmonary disease at the ED."


Secondary outcome:
"Secondary study parameters are time to preliminary imaging result, length of stay at Emergency Department, length of hospital stay, mortality within 28 days, quality of life (SF-12 / SF-6D / EQ5D) at 28 days, direct healthcare costs after 28 days, economic impact after 28 days (iPCQ / iMCQ), number of patients in follow-up because of incidental findings on chest X-ray or ULD chest CT."

replaced by

"To evaluate whether the replacement of chest X-ray by ultra-low-dose chest CT (ULD chest CT) in the diagnostic work-up of patients suspected of non-traumatic pulmonary disease at the Emergency Department leads to more accurate diagnoses and more timely treatment.
To evaluate for patients with clinically suspected community-acquired pneumonia (CAP),
- the diagnostic accuracy and clinical impact of performing ULD chest CT as compared to conventional chest X-ray.
- the accuracy of CT versus conventional X-ray to predict the etiology of the pneumonia.
- the value of new and previously described (molecular) biomarkers for the diagnosis and etiology of CAP."
- RECORD6-dec-2016 - 21-okt-2017


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