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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 June 2016 |
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Main ID: |
NCT02791282 |
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Date of registration:
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01/06/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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CTEPH DIAGNOSIS Europe - MRI
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Scientific title:
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CHANGE-MRI (CTEPH DIAGNOSIS Europe - MRI) |
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Date of first enrolment:
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May 2016 |
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Target sample size:
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1080 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02791282 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 3
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Countries of recruitment
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Germany
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Contacts
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Name:
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Jens Vogel-Claussen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hannover Medical School |
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Name:
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Jens Vogel-Claussen, MD |
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Address:
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Telephone:
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+49 5115323421 |
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Email:
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vogel-claussen.jens@mh-hannover.de |
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Affiliation:
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Name:
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Jens Vogel-Claussen, MD |
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Address:
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Telephone:
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+49 511 5323421 |
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Email:
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vogel-claussen.jens@mh-hannover.de |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Transthoracic echocardiography indicates pulmonary hypertension
- Patients with clinical suspicion for CTEPH, scheduled for SPECT
- Provided informed consent for the study
- Age >18y
Exclusion Criteria:
- Patient unable to undergo MRI (e.g. due to claustrophobia, cardiac pacemaker,
hypersensitivity to MR i.v. contrast imaging agents)
- Women who are pregnant or breast feeding
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Hypertension
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Intervention(s)
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Other: Index test: functional dynamic contrast enhanced (DCE)-MRI
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Primary Outcome(s)
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The proportion of patients with positive MRI in the group of patients with negative VQ-SPECT who are negative in the gold standard
[Time Frame: 6 months]
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The proportion of patients with positive MRI in the group of patients who have a positive VQ-SPECT diagnosis for chronic pulmonary embolism and who are positive in the gold standard
[Time Frame: 6 months]
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Secondary ID(s)
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CHANGE-MRI
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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