Condition category
Circulatory System
Date applied
04/01/2021
Date assigned
05/01/2021
Last edited
06/01/2021
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Elin Good

ORCID ID

http://orcid.org/0000-0002-3418-1706

Contact details

Cardiology Clinic
Linköping University Hospital
Linkoping
58185
Sweden
+46 (0)10 103 00 00
elin.good@liu.se

Type

Scientific

Additional contact

Dr Elin Good

ORCID ID

http://orcid.org/0000-0002-3418-1706

Contact details

Cardiology Clinic
Linköping University Hospital
Linkoping
58185
Sweden
+46 (0)10 103 00 00
elin.good@liu.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 1

Study information

Scientific title

The DTP FDG-PET-MRI study for assessment of inflammation, lipid-rich necrotic core and intraplaque hemorrhage in the atherosclerotic plaque

Acronym

CARMA-PET

Study hypothesis

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

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

Study design

Multicenter observational prospective trial

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet. The original information sheet is written in Swedish.

Condition

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

Phase

Not Applicable

Drug names

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 trial start date

01/06/2017

Overall trial end date

26/10/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

≥50% carotid stenosis (corresponds to a Doppler flow velocity ≥1.3 m/sec at a Doppler angle of 50-60°)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10-20

Total final enrolment

12

Participant 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

Recruitment start date

01/04/2018

Recruitment end date

01/10/2018

Locations

Countries of recruitment

Sweden

Trial participating centre

Linköping University
Department of Health, Medicine and Caring Sciences Linköping University Hospital
Linköping
58183
Sweden

Trial participating centre

Uppsala University
Department of Surgical Sciences Section of Radiology & Molecular Imaging Uppsala University Hospital
Uppsala
751 85
Sweden

Sponsor information

Organisation

Henry och Ella Margareta Ståhls Stiftelse (Henry and Ella Margareta Ståhl’s Foundation)

Sponsor details

c/o Ståhl Invest i Norrköping AB
Garvaregatan 4C
Norrköping
602 21
Sweden
+46 (0)70 417 30 62
sibyl.hagel@stahl.se

Sponsor type

Charity

Website

http://stahl.se/stiftelsen/

Funders

Funder type

Charity

Funder name

Henry och Ella Margareta Ståhls Stiftelse (Henry and Ella Margareta Ståhl’s Foundation)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hjärt-Lungfonden

Alternative name(s)

Swedish Heart-Lung Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

Sweden

Results and Publications

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 statement
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.

Intention to publish date

01/02/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/01/2021: Internal review. 05/01/2021: Trial's existence confirmed by the Swedish Ethical Review Authority.