Chronic Obstructive Pulmonary DiseaseMR-COPDIINCT03591562
Imaging Progression of Chronic Obstructive Pulmonary Disease Using MRI and CT (MR-COPDII)
An observational study of Chronic Obstructive Pulmonary Disease, run by University Hospital Heidelberg at 10 sites in Germany.
Trial summary
In this follow-up trial, MRI and CT images of the lung will be acquired prospectively in a subcohort of 370 patients, three years after they successfully participated in the first COSYCONET subtrial with CT and MRI ("MR-COPD I", NCT (clinical.Trials.gov identifier) 02629432). Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 252 participants
- Where
- 10 sitesGermany
- Study dates
- 10 Nov 2017to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The trial is fully embedded in the COSYCONET cohort and will only comprise participants of the precursor trial performed between 2013 and 2016:Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT (MR-COPD), NCT 02629432.
Who may be able to join
- Patients enrolled into the COSYCONET main cohort (Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis, Utilisation of Health care resources in Patients with COPD (COSYCONET), NCT01245933), having already successfully participated in the COSYCONET subtrial with CT and MRI performed between December 2013 and July 2016 (Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT (MR-COPD), NCT 02629432)
Who cannot join
- Insufficient quality of MRI and CT obtained at baseline (MR-COPD I)
- Having undergone lung surgery (e.g. lung volume reduction, lung transplantation)
- Moderate or severe exacerbation requiring antibiotic treatment within prior to appointment
- Absence of consent
- Inability to understand the intention of the project
- Contraindications to MRI and/or CT
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Universitätsklinikum Gießen und Marburg GmbH,Klinik für Diagnostische und Interventionelle Radiologie
Giessen, 35392
Universitätsmedizin Greifswald, Institut für Diagnostische Radiologie u. Neuroradiologie
Greifswald, 17475
LungenClinic Grosshansdorf, Pneumologisches Forschungsinstitut
Großhansdorf, 22927
Hamburger Institut für Therapieforschung (HIT) GmbH
Hamburg, 20354
Medizinische Hochschule Hannover, Zentrum Radiologie, Institut für Diagnostische und Interventionelle Radiologie
Hanover, 30625
Thoraxklinik Heidelberg, Diagnostische und Interventionelle Radiologie
Heidelberg, 69126
Universitätsklinikum Schleswig Holstein, Klinik für Diagnostische Radiologie, Campus Kiel
Kiel, 24105
Universitätsklinikum, Zentrum für Radiologie, Klinik für Diagnostische und Interventionelle Radiologie
Marburg, 35043
Klinikum der Universität Muenchen, Klinik und Poliklinik für Radiologie
München, 81377
Klinikum Nord-Nuernberg, Radiologie
Nuremberg, 90419
About this study
Official title: Imaging Disease Progression in COPD (MR-COPDII)
In this follow-up trial, MRI and CT images of the lung will be acquired prospectively in a subcohort of 370 patients, three years after they successfully participated in the first COSYCONET subtrial with CT and MRI ("MR-COPD I", NCT (clinical.Trials.gov identifier) 02629432).
The objective is to obtain longitudinal data from a well-characterized collective of COPD patients in order to identify suitable image-based biomarkers to improve the prognosis of disease progression of COPD in comparison to clinical tests
Read the detailed description
There is evidence that both computed tomography (CT) and proton magnetic resonance imaging (1H-MRI) have the potential to detect changes in lung structure and function earlier and with higher sensitivity than currently available clinical tests. We state the hypothesis that the progression of regional lung alterations as detected with MRI and CT precedes the worsening of airflow limitation and clinical symptoms. Before the method can be recommended for patient stratification or for monitoring disease progression, final proof is needed that any changes over time correlate with clinical symptoms and that the quantitative parameters and biomarkers obtained with imaging are predictive for the further course of the disease. Therefore, a dedicated prospective longitudinal trial is required.
The primary end point of the study is to use changes in lung perfusion MRI (e.g. pulmonary blood volume, pulmonary blood flow) and CT (e.g. airway wall thickness, extent of emphysema, extent of air trapping) within a 3-year interval for the prediction of long-term disease progression as monitored by clinical tests (within the following 3 years; BODE index (BODE= body-mass index, airflow obstruction, dyspnea and exercise capacity index in chronic obstructive pulmonary disease). A progression of the disease is defined as an increase of the multidimensional 10-point BODE index by at least one point.
This is an exploratory study. The local two-sided type-I error rate is set to 5%.
Statistical analysis will be primarily conducted as a complete case analysis. Logistic regression models with dependent variable COPD progression will be used. Imaging biomarkers are used as independent variables. All models are adjusted for the prognostic factors age, sex, GOLD (GOLD= Global Initiative For Chronic Obstructive Lung Disease) stage and smoking status as well as the factor study center.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- MRI, COPD, Disease Progression
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COSYCONET COPD Subcohort | MRI and CT of the lung will be performed in a multi-centre subcohort of 370 patients having already participated in the precursor trial " Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT (MR-COPD)", NCT 02629432. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of pulmonary blood flow calculated from first pass perfusion MRI to predict disease progression in COPD
Changes from baseline in MRI-based lung perfusion: pulmonary blood flow (PBF)
Measured: Baseline: December 2013-July 2016 Follow-Up: November 2017-June 2020
Sensitivity and specificity of pulmonary blood volume calculated from first pass perfusion MRI to predict disease progression in COPD
Changes from baseline in MRI-based lung perfusion: pulmonary blood volume (PBV)
Measured: Baseline: December 2013-July 2016 Follow-Up: November 2017-June 2020
Sensitivity and specificity of visual perfusion deficit on first pass perfusion MRI to predict disease progression in COPD
Changes from baseline in MRI-based lobar perfusion deficit score (visual 4-point rating scale: 0=normal perfusion, 1= mild heterogeneities, 2= perfusion defects affecting up to 50% of a lobe, 3= perfusion defects affecting more than 50% of the lobe). Lobar scores are summed up to a total perfusion deficit score for each patient. A completely healthy subject with unimpared lung perfusion would be scored as "0" (best possible result), while the result for more than 50% involvement of all lung lobes would be scored as "18" (worst possible result).
Measured: December 2013-July 2016 Follow-Up: November 2017-June 2020
Sensitivity and specificity of airway wall metrics on CT to predict disease progression in COPD
Changes from baseline in CT-based metrics for the extent of airway wall thickening (standardized airway wall thickness: PI10)
Measured: Baseline: December 2013-July 2016 Follow-Up: November 2017-June 2020
Sensitivity and specificity of emphysema quantification with CT to predict disease progression in COPD
Changes from baseline in CT-based metrics for the extent of emphysema (low attenuation areas in percent of total lung volume: LAA%)
Measured: Baseline: December 2013-July 2016 Follow-Up: November 2017-June 2020
Sensitivity and specificity of air trapping on expiratory CT to predict disease progression in COPD
Changes from baseline in CT-based metrics for the extent air trapping (expiratory to inspiratory ratio of mean lung density (E/I-MLD)
Measured: Baseline: December 2013-July 2016 Follow-Up: November 2017-June 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start10 Nov 2017
- Primary completion31 Dec 2019
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Philipps University Marburg, Hannover Medical School, German Center for Lung Research
- Responsible party
- Principal investigator, Prof. Dr. Juergen Biederer, University Hospital Heidelberg
- Investigators
- Juergen Biederer, Prof, Principal investigator, University Hosital HeidelbergBertram J. Jobst, MD, Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591562
- Sponsor's protocol ID
- 82DZLS24A1
- Acronym
- MR-COPDII
- Status last verified
- May 2024
- First submitted
- 17 Feb 2018
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized Data from structured image reads will be transferred to the central COSYCONET data base at Hannover Medical School.
Publications
Biederer J, Mirsadraee S, Beer M, Molinari F, Hintze C, Bauman G, Both M, Van Beek EJ, Wild J, Puderbach M. MRI of the lung (3/3)-current applications and future perspectives. Insights Imaging. 2012 Aug;3(4):373-86. doi: 10.1007/s13244-011-0142-z. Epub 2012 Jan 15.
PubMed 22695943Biederer J, Beer M, Hirsch W, Wild J, Fabel M, Puderbach M, Van Beek EJ. MRI of the lung (2/3). Why ... when ... how? Insights Imaging. 2012 Aug;3(4):355-71. doi: 10.1007/s13244-011-0146-8. Epub 2012 Feb 13.
PubMed 22695944Wild JM, Marshall H, Bock M, Schad LR, Jakob PM, Puderbach M, Molinari F, Van Beek EJ, Biederer J. MRI of the lung (1/3): methods. Insights Imaging. 2012 Aug;3(4):345-53. doi: 10.1007/s13244-012-0176-x. Epub 2012 Jun 13.
PubMed 22695952COPDGene CT Workshop Group; Barr RG, Berkowitz EA, Bigazzi F, Bode F, Bon J, Bowler RP, Chiles C, Crapo JD, Criner GJ, Curtis JL, Dass C, Dirksen A, Dransfield MT, Edula G, Erikkson L, Friedlander A, Galperin-Aizenberg M, Gefter WB, Gierada DS, Grenier PA, Goldin J, Han MK, Hanania NA, Hansel NN, Jacobson FL, Kauczor HU, Kinnula VL, Lipson DA, Lynch DA, MacNee W, Make BJ, Mamary AJ, Mann H, Marchetti N, Mascalchi M, McLennan G, Murphy JR, Naidich D, Nath H, Newell JD Jr, Pistolesi M, Regan EA, Reilly JJ, Sandhaus R, Schroeder JD, Sciurba F, Shaker S, Sharafkhaneh A, Silverman EK, Steiner RM, Strange C, Sverzellati N, Tashjian JH, van Beek EJ, Washington L, Washko GR, Westney G, Wood SA, Woodruff PG. A combined pulmonary-radiology workshop for visual evaluation of COPD: study design, chest CT findings and concordance with quantitative evaluation. COPD. 2012 Apr;9(2):151-9. doi: 10.3109/15412555.2012.654923. Epub 2012 Mar 19.
PubMed 22429093Gietema HA, Muller NL, Fauerbach PV, Sharma S, Edwards LD, Camp PG, Coxson HO; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) investigators. Quantifying the extent of emphysema: factors associated with radiologists' estimations and quantitative indices of emphysema severity using the ECLIPSE cohort. Acad Radiol. 2011 Jun;18(6):661-71. doi: 10.1016/j.acra.2011.01.011. Epub 2011 Mar 9.
PubMed 21393027Karch A, Vogelmeier C, Welte T, Bals R, Kauczor HU, Biederer J, Heinrich J, Schulz H, Glaser S, Holle R, Watz H, Korn S, Adaskina N, Biertz F, Vogel C, Vestbo J, Wouters EF, Rabe KF, Sohler S, Koch A, Jorres RA; COSYCONET Study Group. The German COPD cohort COSYCONET: Aims, methods and descriptive analysis of the study population at baseline. Respir Med. 2016 May;114:27-37. doi: 10.1016/j.rmed.2016.03.008. Epub 2016 Mar 11.
PubMed 27109808Jorres RA, Welte T, Bals R, Koch A, Schnoor M, Vogelmeier C. [Systemic manifestations and comorbidities in patients with chronic obstructive pulmonary disease (COPD) and their effect on clinical state and course of the disease--an overview of the cohort study COSYCONET]. Dtsch Med Wochenschr. 2010 Mar;135(10):446-9. doi: 10.1055/s-0030-1249185. Epub 2010 Mar 2. German.
PubMed 20198540
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Disease Progression in COPD (MR-COPDII)
- ClinicalTrials.gov ID
- NCT03591562
- Acronym / sponsor ID
- MR-COPDII / 82DZLS24A1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- MRI, COPD, Disease Progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Philipps University Marburg, Hannover Medical School, German Center for Lung Research
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this follow-up trial, MRI and CT images of the lung will be acquired prospectively in a subcohort of 370 patients, three years after they successfully participated in the first COSYCONET subtrial with CT and MRI ("MR-COPD I", NCT (clinical.Trials.gov identifier) 02629432).
The objective is to obtain longitudinal data from a well-characterized collective of COPD patients in order to identify suitable image-based biomarkers to improve the prognosis of disease progression of COPD in comparison to clinical tests
Detailed description
There is evidence that both computed tomography (CT) and proton magnetic resonance imaging (1H-MRI) have the potential to detect changes in lung structure and function earlier and with higher sensitivity than currently available clinical tests. We state the hypothesis that the progression of regional lung alterations as detected with MRI and CT precedes the worsening of airflow limitation and clinical symptoms. Before the method can be recommended for patient stratification or for monitoring disease progression, final proof is needed that any changes over time correlate with clinical symptoms and that the quantitative parameters and biomarkers obtained with imaging are predictive for the further course of the disease. Therefore, a dedicated prospective longitudinal trial is required.
The primary end point of the study is to use changes in lung perfusion MRI (e.g. pulmonary blood volume, pulmonary blood flow) and CT (e.g. airway wall thickness, extent of emphysema, extent of air trapping) within a 3-year interval for the prediction of long-term disease progression as monitored by clinical tests (within the following 3 years; BODE index (BODE= body-mass index, airflow obstruction, dyspnea and exercise capacity index in chronic obstructive pulmonary disease). A progression of the disease is defined as an increase of the multidimensional 10-point BODE index by at least one point.
This is an exploratory study. The local two-sided type-I error rate is set to 5%.
Statistical analysis will be primarily conducted as a complete case analysis. Logistic regression models with dependent variable COPD progression will be used. Imaging biomarkers are used as independent variables. All models are adjusted for the prognostic factors age, sex, GOLD (GOLD= Global Initiative For Chronic Obstructive Lung Disease) stage and smoking status as well as the factor study center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COSYCONET COPD Subcohort | – | –MRI and CT of the lung will be performed in a multi-centre subcohort of 370 patients having already participated in the precursor trial " Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT (MR-COPD)", NCT 02629432. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The trial is fully embedded in the COSYCONET cohort and will only comprise participants of the precursor trial performed between 2013 and 2016:Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT (MR-COPD), NCT 02629432.
Key inclusion criteria (1 listed)
- Patients enrolled into the COSYCONET main cohort (Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis, Utilisation of Health care resources in Patients with COPD (COSYCONET), NCT01245933), having already successfully participated in the COSYCONET subtrial with CT and MRI performed between December 2013 and July 2016 (Image-Based Structural and Functional Phenotyping of the COSYCONET Cohort Using MRI and CT (MR-COPD), NCT 02629432)
Key exclusion criteria (6 listed)
- Insufficient quality of MRI and CT obtained at baseline (MR-COPD I)
- Having undergone lung surgery (e.g. lung volume reduction, lung transplantation)
- Moderate or severe exacerbation requiring antibiotic treatment within prior to appointment
- Absence of consent
- Inability to understand the intention of the project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity of pulmonary blood flow calculated from first pass perfusion MRI to predict disease progression in COPD
Time frame: Baseline: December 2013-July 2016 Follow-Up: November 2017-June 2020
Changes from baseline in MRI-based lung perfusion: pulmonary blood flow (PBF)
Sensitivity and specificity of pulmonary blood volume calculated from first pass perfusion MRI to predict disease progression in COPD
Time frame: Baseline: December 2013-July 2016 Follow-Up: November 2017-June 2020
Changes from baseline in MRI-based lung perfusion: pulmonary blood volume (PBV)
Sensitivity and specificity of visual perfusion deficit on first pass perfusion MRI to predict disease progression in COPD
Time frame: December 2013-July 2016 Follow-Up: November 2017-June 2020
Changes from baseline in MRI-based lobar perfusion deficit score (visual 4-point rating scale: 0=normal perfusion, 1= mild heterogeneities, 2= perfusion defects affecting up to 50% of a lobe, 3= perfusion defects affecting more than 50% of the lobe). Lobar scores are summed up to a total perfusion deficit score for each patient. A completely healthy subject with unimpared lung perfusion would be scored as "0" (best possible result), while the result for more than 50% involvement of all lung lobes would be scored as "18" (worst possible result).
Sensitivity and specificity of airway wall metrics on CT to predict disease progression in COPD
Time frame: Baseline: December 2013-July 2016 Follow-Up: November 2017-June 2020
Changes from baseline in CT-based metrics for the extent of airway wall thickening (standardized airway wall thickness: PI10)
Sensitivity and specificity of emphysema quantification with CT to predict disease progression in COPD
Time frame: Baseline: December 2013-July 2016 Follow-Up: November 2017-June 2020
Changes from baseline in CT-based metrics for the extent of emphysema (low attenuation areas in percent of total lung volume: LAA%)
Sensitivity and specificity of air trapping on expiratory CT to predict disease progression in COPD
Time frame: Baseline: December 2013-July 2016 Follow-Up: November 2017-June 2020
Changes from baseline in CT-based metrics for the extent air trapping (expiratory to inspiratory ratio of mean lung density (E/I-MLD)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Background: PubMed 22695943Biederer J, Mirsadraee S, Beer M, Molinari F, Hintze C, Bauman G, Both M, Van Beek EJ, Wild J, Puderbach M. MRI of the lung (3/3)-current applications and future perspectives. Insights Imaging. 2012 Aug;3(4):373-86. doi: 10.1007/s13244-011-0142-z. Epub 2012 Jan 15.
- Background: PubMed 22695944Biederer J, Beer M, Hirsch W, Wild J, Fabel M, Puderbach M, Van Beek EJ. MRI of the lung (2/3). Why ... when ... how? Insights Imaging. 2012 Aug;3(4):355-71. doi: 10.1007/s13244-011-0146-8. Epub 2012 Feb 13.
- Background: PubMed 22695952Wild JM, Marshall H, Bock M, Schad LR, Jakob PM, Puderbach M, Molinari F, Van Beek EJ, Biederer J. MRI of the lung (1/3): methods. Insights Imaging. 2012 Aug;3(4):345-53. doi: 10.1007/s13244-012-0176-x. Epub 2012 Jun 13.
- Background: PubMed 22429093COPDGene CT Workshop Group; Barr RG, Berkowitz EA, Bigazzi F, Bode F, Bon J, Bowler RP, Chiles C, Crapo JD, Criner GJ, Curtis JL, Dass C, Dirksen A, Dransfield MT, Edula G, Erikkson L, Friedlander A, Galperin-Aizenberg M, Gefter WB, Gierada DS, Grenier PA, Goldin J, Han MK, Hanania NA, Hansel NN, Jacobson FL, Kauczor HU, Kinnula VL, Lipson DA, Lynch DA, MacNee W, Make BJ, Mamary AJ, Mann H, Marchetti N, Mascalchi M, McLennan G, Murphy JR, Naidich D, Nath H, Newell JD Jr, Pistolesi M, Regan EA, Reilly JJ, Sandhaus R, Schroeder JD, Sciurba F, Shaker S, Sharafkhaneh A, Silverman EK, Steiner RM, Strange C, Sverzellati N, Tashjian JH, van Beek EJ, Washington L, Washko GR, Westney G, Wood SA, Woodruff PG. A combined pulmonary-radiology workshop for visual evaluation of COPD: study design, chest CT findings and concordance with quantitative evaluation. COPD. 2012 Apr;9(2):151-9. doi: 10.3109/15412555.2012.654923. Epub 2012 Mar 19.
- Background: PubMed 21393027Gietema HA, Muller NL, Fauerbach PV, Sharma S, Edwards LD, Camp PG, Coxson HO; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) investigators. Quantifying the extent of emphysema: factors associated with radiologists' estimations and quantitative indices of emphysema severity using the ECLIPSE cohort. Acad Radiol. 2011 Jun;18(6):661-71. doi: 10.1016/j.acra.2011.01.011. Epub 2011 Mar 9.
- Background: PubMed 27109808Karch A, Vogelmeier C, Welte T, Bals R, Kauczor HU, Biederer J, Heinrich J, Schulz H, Glaser S, Holle R, Watz H, Korn S, Adaskina N, Biertz F, Vogel C, Vestbo J, Wouters EF, Rabe KF, Sohler S, Koch A, Jorres RA; COSYCONET Study Group. The German COPD cohort COSYCONET: Aims, methods and descriptive analysis of the study population at baseline. Respir Med. 2016 May;114:27-37. doi: 10.1016/j.rmed.2016.03.008. Epub 2016 Mar 11.
- Background: PubMed 20198540Jorres RA, Welte T, Bals R, Koch A, Schnoor M, Vogelmeier C. [Systemic manifestations and comorbidities in patients with chronic obstructive pulmonary disease (COPD) and their effect on clinical state and course of the disease--an overview of the cohort study COSYCONET]. Dtsch Med Wochenschr. 2010 Mar;135(10):446-9. doi: 10.1055/s-0030-1249185. Epub 2010 Mar 2. German.
- Individual participant dataSharing planned: Yes. Pseudonymized Data from structured image reads will be transferred to the central COSYCONET data base at Hannover Medical School.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juergen Biederer, Prof principal investigator
University Hosital Heidelberg
Bertram J. Jobst, MD principal investigator
University Hospital Heidelberg
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by University Hospital Heidelberg at 10 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of pulmonary blood flow calculated from first pass perfusion MRI to predict disease progression in COPD (time frame: Baseline: December 2013-July 2016 Follow-Up: November 2017-June 2020). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03591562, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.