Investigating the contents of atherosclerotic plaques using novel imaging techniques including PET/MRI
| ISRCTN | ISRCTN30673005 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30673005 |
| Secondary identifying numbers | IRAS 1 |
- Submission date
- 04/01/2021
- Registration date
- 05/01/2021
- Last edited
- 11/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Atherosclerosis is the deadliest disease worldwide. It is caused by the buildup of fats, cholesterol and other substances in and on the artery walls (plaque), which can restrict blood flow. Most deaths are caused by the rupture (bursting) of plaques, leading to arterial thrombosis (blood clot) and occlusion (blockage), resulting in a heart attack or stroke. Early detection of rupture-prone plaques would provide opportunities for treatment before fatal or disabling cardiovascular events. Previous research has shown that factors strongly associated with plaque rupture are inflammation and elevated contents of fat (the lipid core) and blood (hemorrhage within the plaque). Therefore, these plaque characteristics are associated with a high risk of cardiovascular events.
Researchers have developed a new and validated MRI technique for measuring fat and blood within plaques. In this study, for the first time, the aim is to measure not only fat and blood, but also plaque inflammation. The study of correlations between these high-risk plaque features will provide new information on atherosclerotic plaque biology, and will hopefully lead to new methods to identify high-risk individuals.
Who can participate?
Patients aged 80 or under with high-grade carotid stenosis (narrowing of the carotid arteries)
What does the study involve?
All patients undergo one MRI scan and one whole-body PET/MRI scan in order to create images of the carotid arteries.
What are the possible benefits and risks of participating?
The PET scan involves a low dose of radiation, 5 mS. However, the risk to the patients of developing any side effects related to this is considered very low, as their mean age is over 70. The benefit is the possibility that the study contributes to the development of better tests for plaque risk assessment in the future.
Where is the study run from?
Linköping University and Uppsala University (Sweden)
When is the study starting and how long is it expected to run for?
June 2017 to October 2018
Who is funding the study?
1. Henry och Ella Margareta Ståhls Stiftelse (Henry and Ella Margareta Ståhl’s Foundation) (Sweden)
2. Swedish Heart-Lung Foundation (Sweden)
Who is the main contact?
Dr Elin Good
elin.good@liu.se
Contact information
Public
Cardiology Clinic
Linköping University Hospital
Linkoping
58185
Sweden
 ORCID ID |
0000-0002-3418-1706 |
|---|---|
| Phone | +46 (0)10 103 00 00 |
| elin.good@liu.se |
Scientific
Cardiology Clinic
Linköping University Hospital
Linkoping
58185
Sweden
| ORCID ID |
0000-0002-3418-1706 |
|---|---|
| Phone | +46 (0)10 103 00 00 |
| elin.good@liu.se |
Study information
| Study design | Multicenter observational prospective trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN30673005_PIS.docx |
| Scientific title | The DTP FDG-PET-MRI study for assessment of inflammation, lipid-rich necrotic core and intraplaque hemorrhage in the atherosclerotic plaque |
| Study acronym | CARMA-PET |
| Study objectives | The degree of inflammation in the atherosclerotic plaque is correlated to the quantity of fat (lipid-rich necrotic core) and the quantity of blood (intraplaque haemorrhage), as all these three are associated with plaque rupture. |
| Ethics approval(s) | Approved 12/01/2018, Swedish Ethical Review Authority (Swedish Ethical Review Authority, Box 2110, 750 02 Uppsala; +46 (0)10 475 08 00; registrator@etikprovning.se), ref: 2017/545-31 |
| Health condition(s) or problem(s) studied | Atherosclerotic plaque composition in patients with high-grade carotid stenosis |
| Intervention | In patients with high-grade carotid stenosis the extent of lipid-rich necrotic core and intraplaque hemorrhage is quantified from fat and R2* maps acquired with a previously validated four-point Dixon MRI sequence in a stand-alone MRI. PET/MRI is used to measure 18F-FDG uptake. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Lipid-rich necrotic cores (fat) and intraplaque hemorrhage (blood) in atherosclerotic plaques are measured using a novel and thoroughly validated quantitative MRI (qMRI) technique at study baseline 2. Inflammation measured using 18F-fluoro-deoxyglucose (18F- FDG) uptake quantified in the same plaques on images acquired using a simultaneous whole-body PET/MRI scanner at study baseline, as close in time to the qMRI assessment as possible |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/06/2017 |
| Completion date | 26/10/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10-20 |
| Total final enrolment | 12 |
| Key inclusion criteria | ≥50% carotid stenosis (corresponds to a Doppler flow velocity ≥1.3 m/sec at a Doppler angle of 50-60°) |
| Key exclusion criteria | 1. Previous carotid endarterectomy 2. Carotid occlusion 3. Diabetes mellitus 4. Renal failure (GFR <45 ml/min/1.73m²) 5. Inflammatory diseases including malignancies, immunologic disorders 6. Treatment with immunosuppressive/anti-inflammatory agents |
| Date of first enrolment | 01/04/2018 |
| Date of final enrolment | 01/10/2018 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Linköping University Hospital
Linköping
58183
Sweden
Section of Radiology & Molecular Imaging
Uppsala University Hospital
Uppsala
751 85
Sweden
Sponsor information
Charity
c/o Ståhl Invest i Norrköping AB
Garvaregatan 4C
Norrköping
602 21
Sweden
| Phone | +46 (0)70 417 30 62 |
|---|---|
| sibyl.hagel@stahl.se | |
| Website | http://stahl.se/stiftelsen/ |
Funders
Funder type
Charity
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swedish Heart-Lung Foundation
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/02/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. The study protocol and statistical analysis plan will be available immediately following publication. The documents, however, will not available in web format, please use the contact details to request copies of the documentation. 2. Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Elin Good (elin.good@liu.se). Individual participant data that underlie the results reported in published manuscripts will be available immediately following publication, after deidentification (text, tables, figures, and appendices). This information may be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. The information may be used to achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in the University's data warehouse but without investigator support other than deposited metadata. Written informed consent from all participants was obtained. All data is anonymized. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/02/2021 | No | Yes | ||
| Results article | results | 09/07/2021 | 11/08/2021 | Yes | No |
Additional files
- ISRCTN30673005_PIS.docx
- uploaded 04/02/2021
Editorial Notes
11/08/2021: Internal review.
12/07/2021: Publication reference added.
04/02/2021: The participant information sheet was uploaded as an additional file.
06/01/2021: Internal review.
05/01/2021: Trial's existence confirmed by the Swedish Ethical Review Authority.
