Imaging Disease Progression in COPD

Conditions: J44
Other chronic obstructive pulmonary disease

Registration Number: DRKS00014715

Lead Sponsor: niversitätsklinikum Heidelberg Klinik Diagnostische und Interventionelle Radiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 252

Inclusion Criteria

• Patients enrolled into the COSYCONET main cohort of COPD (Chronic Obstructive Pulmonary Disease) patients, having already participated in the COSYCONET subtrial with CT and MRI performed between December 2013 and July 2016 (MR-COPD I”, COSYCONET Subproject 7);
• MRI and CT images obtained in sufficient quality at baseline (MR-COPD-I”)

Exclusion Criteria

• Having undergone lung surgery (e.g. lung volume reduction, lung transplantation)
• Replaced pneumonia (antibiotic treatment necessary) in the last four weeks.
• Moderate or severe exacerbation requiring antibiotic treatment within the last 4 weeks prior to appointment
• Absence of informed consent
• Inability to understand the intention of the project
• Missing or incomplete MRI or CT examination in baseline (MR-COPD I).
• Insufficient quality of MRI and CT obtained at baseline (MR-COPD I)

Contraindications to CT and MRI:
• Due to the strong magnetic field
- patients with pacemaker
- patients with incompatible metallic implants
• Due to the use of Gadolinium based contrast agent
- allergy
- acute and chronic renal insufficiency (GFR <40 ml / min according to MDRD calculation)
• Pregnancy
• Claustrophobia
• Acute psychoses or other conditions that make the perception of the patient appear limited

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of suitable image-based biomarkers to improve the prognosis of disease progression of COPD (Chronic Obstructive Pulmonary Disease) in comparison to clinical tests: <br>• Use of the image-based assessment of the course of COPD: changes in lung perfusion MRI (e.g. PBV, PBF) and CT (e.g. PI10, LAA%, E/I-MLD) 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) . A progression of the disease is defined as an increase of the multidimensional 10-point BODE index by at least one point.<br>

Secondary Outcome Measures