Assessing heart problems in psoriasis patients using cardiovascular magnetic resonance (CMR) imaging
| ISRCTN | ISRCTN71534700 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71534700 |
- Submission date
- 25/05/2023
- Registration date
- 09/06/2023
- Last edited
- 21/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Psoriasis is a chronic inflammatory disease with primary skin manifestation caused by a complex interaction of the immune system. It is characterized by erythematous plaques with silvery-white scales at typical predilection sites. Nail changes and joint involvement may also occur. Psoriasis is mainly treated with anti-inflammatory agents, in mild cases by local application of anti-inflammatory lotions or other creams and in moderate to severe cases by systemic treatment with immunomodulatory drugs such as biologicals.
It is already known that patients with psoriasis have an increased prevalence of cardiovascular risk factors such as metabolic syndrome, diabetes mellitus and hypertension. Patients with psoriasis are more frequently affected by severe cardiac events such as heart attacks or strokes. Consequently, cardiovascular disease significantly affects the morbidity and mortality of patients with psoriasis.
The aim of this study is the investigation of a potential myocardial involvement by cardiovascular magnetic resonance imaging (CMR) in patients with psoriasis. Subordinate to this, it will be investigated whether the severity of the disease, defined according to the therapy, correlates with the changes in the myocardium.
Who can participate?
This study includes patients diagnosed with psoriasis who also meet the following conditions:
- Age: 18 years or older
- No known severe cardiovascular disease such as coronary artery disease, myocardial infarction or condition after bypass surgery
- No pregnancy or lactation
- No general contraindications for an MRI examination (e.g. metallic implants)
What does the study involve?
All patients receive one MRI scan. In addition, a dermatologic and cardiac physical exam, a general blood test and ECG are performed.
What are the possible benefits and risks of participating?
All participants receive a cardiological check by CMR and complementary examinations, providing assessment and evaluation of cardiac function and other heart abnormalities.
Where is the study run from?
Charité Universitätsmedizin Berlin (Germany) and HELIOS Klinikum Berlin-Buch (Germany)
When is the study starting and how long is it expected to run for?
February 2021 to March 2023
Who is funding the study?
Charité Universitätsmedizin Berlin (Germany)
Who is the main contact?
Prof. Dr. Jeanette Schulz-Menger
jeanette.schulz-menger@charite.de
Contact information
Scientific
Charité Universitätsmedizin Berlin
Campus Berlin Buch – ECRC
AG Kardiale MRT - Prof. Schulz-Menger
Lindenberger Weg 80
Berlin
13125
Germany
| Phone | +49 (0)30 450 540 615 |
|---|---|
| leonhard.grassow@charite.de |
Scientific
Charité Universitätsmedizin Berlin
Campus Berlin Buch – ECRC
AG Kardiale MRT - Prof. Schulz-Menger
Lindenberger Weg 80
Berlin
13125
Germany
| Phone | +49 (0)30 450 540 615 |
|---|---|
| jan.groeschel@charite.de |
Study information
| Study design | Prospective observational single-center cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Deep cardiac phenotyping by cardiovascular magnetic resonance (CMR) in patients with psoriasis for the detection of potential myocardial tissue injury. PSORiasis assessment by CardiOvascular magnetic Resonance |
| Study acronym | PSOR-COR |
| Study objectives | 1. Patients with psoriasis but without severe previous cardiac disease show more myocardial tissue damage by late gadolinium enhancement (LGE) or parametric techniques in CMR compared to a healthy control group. 2. Higher severity of psoriasis correlates positively with detected myocardial damage. Myocardial damage includes scar/fibrosis, edema, fatty infiltration and should be detected by LGE, and parametric techniques. 3. Patients with psoriasis have larger epi- and pericardial fat mass, as measured by Fat/Water sequences on CMR, compared to a healthy control group. 4. Inflammatory markers determined by blood tests correlate positively with the potential myocardial injury. |
| Ethics approval(s) | Approved 15/06/2021, Ethics Committee of Charité University Medicine Berlin Campus Mitte (Charité Medical Faculty, Charité – Universitätsmedizin Berlin, Campus Charité Mitte, Charitéplatz 1, 10117 Berlin, Germany; +49 (0)30 450 517 222; ethikkommission@charite.de), ref: EA1/130/21 |
| Health condition(s) or problem(s) studied | Myocardial involvement in patients with psoriasis. |
| Intervention | All patients undergo cardiovascular magnetic resonance (CMR) at a 1.5 Tesla scanner with application of contrast agent to evaluate potential cardiac involvement. The images are evaluated qualitatively and quantitatively for cardiac function, dimension and mass (cine technique), signs of inflammation or diffuse fibrosis (mapping techniques), and focal fibrosis (late gadolinium enhancement). Blood tests are performed prior to the scan to determine blood count, inflammatory markers, lipids, renal function, and cardiac-specific parameters such as NTproBNP, high-sensitive troponin T. A physical examination and ECG are also performed prior to the scan. |
| Intervention type | Other |
| Primary outcome measure | Myocardial T1 and T2 times determined by mapping techniques and detection and size of myocardial focal fibrosis by late gadolinium enhancement techniques and extracellular volume (ECV) by applying CMR once (single timepoint). |
| Secondary outcome measures | 1. Quantitative cardiac parameters regarding function, dimension and mass of the ventricles and atria using cine-imaging techniques by applying CMR once (single timepoint). 2. Analysis of function by measuring cardiac deformation (strain) to determine longitudinal, circumferential and radial strain by applying CMR once (single timepoint). |
| Overall study start date | 01/02/2021 |
| Completion date | 31/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 patients with psoriasis, 60 healthy volunteers (healthy volunteers already included in previous studies) |
| Total final enrolment | 64 |
| Key inclusion criteria | 1. Signed consent 2. Age ≥18 years (no upper limit) 3. Verified psoriasis without any of the pre-existing conditions listed under exclusion criteria |
| Key exclusion criteria | 1. Absolute contraindication for MRI examination 2. Severe previous cardiac disease in particular: Condition after myocardial infarction, Condition after CABG (aorto-coronary vein bypass), Coronary artery disease with or without condition after intervention (stenting) 3. Known allergy to MRI contrast agents 4. Chronic kidney disease with GFR <30ml/min (after CKD-EPI) 5. Pregnancy, lactation |
| Date of first enrolment | 01/02/2022 |
| Date of final enrolment | 06/03/2023 |
Locations
Countries of recruitment
- Germany
Study participating centres
Berlin
13125
Germany
Berlin
13125
Germany
Berlin
13125
Germany
Sponsor information
Hospital/treatment centre
Campus Berlin Buch - ECRC
Working Group Kardiale MRT
Lindenberger Weg 80
Berlin
13125
Germany
| Phone | +49 (0)30 940152903 |
|---|---|
| jeanette.schulz-menger@charite.de | |
| Website | https://www.charite.de/en/ |
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
University/education
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medical School - Charité - University Medicine Berlin
- Location
- Germany
Results and Publications
| Intention to publish date | 01/08/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to data protection laws in Germany. However, upon request the methodology and dataset structure can be shared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 16/05/2024 | 21/05/2024 | Yes | No |
Editorial Notes
21/05/2024: Publication reference added.
30/05/2023: Study's existence confirmed by the Ethics Committee of Charité University Medicine Berlin Campus Mitte.
