Investigating the impact of coronavirus infection (COVID-19) on cardiovascular injury using multiple imaging methods
| ISRCTN | ISRCTN12154994 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12154994 |
| Secondary identifying numbers | 2020/IERC-74 |
- Submission date
- 14/07/2020
- Registration date
- 14/08/2020
- Last edited
- 15/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The number of people diagnosed with the coronavirus (COVID-19) infection has surpassed 8 million worldwide claiming over 500,000 deaths. Patients with underlying cardiovascular diseases (diseases of the heart and blood vessels) are more severely affected, with one in three patients showing evidence of heart injury. and have a substantially higher death rate from the virus.
Currently, the underlying mechanism for heart injury in patients with COVID-19 is uncertain. Heart complications from COVID-19 is an important cause of both disability and death. A better understanding of the impact of COVID-19 on cardiovascular health in African populations is urgently needed. Firstly, recent reports have indicated that people of African origin are disproportionately affected and experience the most severe manifestations of infection. Second, the prevalence of high blood pressure and additional risk factors such as HIV are much higher in sub-Saharan Africa and may impact overall rates of disability and death. Third, health systems in sub-Saharan Africa require data to guide future treatments to avoid short- and long-term consequences of COVID-19 on the cardiovascular health of populations.
Who can participate?
Adult patients with COVID-19
What does the study involve?
The study will investigate structural and functional changes of the heart muscle and arteries using various imaging techniques (known as a combined CT coronary angiogram/fluorodeoxyglucose (FDG) PET scan and a cardiac MRI scan) to evaluate evidence of inflammation, scarring in the heart muscle and prevalence of underlying blockage in the arteries supplying the heart. Blood testing will be also undertaken to measure markers of heart injury, strain, and general inflammation in the blood.
What are the possible benefits and risks of participating?
The possible benefits are from closer medical supervision and the scan may identify important findings. However, there may be no direct benefit from participating in this study. Importantly, participating in clinical research may provide benefit to the wider population.
It is not thought that there are many disadvantages; however, as with any medical procedure or medication there are some risks. Performing the PET and CT scans will expose patients to a small dose of radiation. The amount of radiation varies but is around 7 times the amount individuals would normally receive in a year from background natural sources of radiation. There is also a very low risk of impairment of kidney function. This risk will be further minimised by excluding patients who have significant kidney disease.
Where is the study run ?
Aga Khan University Hospital (Kenya)
When is the study starting and how long is it expected to run for?
From March 2020 to March 2021
Who is the funding from?
The global challenges research fund, University of Edinburgh (UK)
Who is the main contact?
1. Dr Anoop Shah
anoop.shah@lshtm.ac.uk
2. Dr Shirjel Alam
shirjel.alam1@nhs.uk
Contact information
Scientific
Southmoor Rd
Roundthorn Industrial Estate
Wythenshawe
Manchester
M23 9LT
United Kingdom
 ORCID ID |
0000-0002-2099-612X |
|---|---|
| Phone | +44 (0)161 998 7070 |
| shirjel.alam1@nhs.uk |
Scientific
Room 249
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
| ORCID ID |
0000-0002-2825-3419 |
|---|---|
| Phone | +44 (0)7766544156 |
| anoop.shah@lshtm.ac.uk |
Study information
| Study design | Single-centre observational cross-sectional multimodality imaging and biomarker study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | CardiOvaScular Mechanisms In Covid-19 (COSMIC-19): A multimodality imaging study |
| Study acronym | COSMIC-19 |
| Study objectives | The mechanisms and pathological sequelae of Covid-19 induced cardiovascular injury can be identified by multi-modality imaging. |
| Ethics approval(s) | Approved 02/06/2020, Nairobi Institutional Ethics Review Committee (IERC) (3rd Parklands Avenue, off Limuru Road, P.O. Box 30270, GPO 00100, Nairobi, Kenya; +254 203662107/2109; research.support@aku.edu), ref: 2020/IERC-74 (v2) |
| Health condition(s) or problem(s) studied | Cardiovascular injury (primary inflammatory, ischaemic, or secondary to systemic pathophysiology) in the context of COVID-19 infection |
| Intervention | Participants with confirmed COVID-19 will undergo biomarker analysis, using Troponin, Brain Natriuretic Peptide (BNP), and C-Reactive Protein (CRP) to assess for evidence of cardiovascular injury. A subgroup of 30 participants with confirmed COVID-19 will be recruited, so that 20 patients with evidence of heart injury, and 10 patients without are included in the study. Study participants will undergo a combined CT coronary angiogram/flurodeoxyglucose (FDG) PET scan and a cardiac MRI scan as part of the study. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Proportion of COVID-19 patients with evidence of cardiovascular injury measured using CT, CMR, or FDG-PET scan within 2 weeks of admission |
| Secondary outcome measures | Explore mechanisms of cardiovascular injury associated with COVID-19 measured using CT, CMR, or FDG-PET scan within 2 weeks of admission |
| Overall study start date | 23/03/2020 |
| Completion date | 01/03/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. COVID19 positive test within the previous 2 weeks (can be extended to 4 weeks at the investigator's discretion) 2. Aged ≥18 years |
| Key exclusion criteria | 1. Prior diagnosis of myocardial infarction 2. Requiring invasive or non-invasive ventilation 3. Previous coronary revascularisation or cardiac surgery 4. Unable to undergo CT or CMR scanning, due to severe renal failure (estimated glomerular filtration rate <30 ml/min) or major allergy to iodinated contrast media /gadolinium 5. Pregnancy or breast feeding 6. Unable to give informed consent 7. Contraindication to imaging example metal fragments in the eye |
| Date of first enrolment | 29/06/2020 |
| Date of final enrolment | 01/03/2021 |
Locations
Countries of recruitment
- Kenya
Study participating centre
PO Box 30270
Nairobi
GPO 00100
Kenya
Sponsor information
Hospital/treatment centre
3rd Parklands Avenue
Limuru Road
Nairobi
GPO 00100
Kenya
| Phone | +254 203662107 |
|---|---|
| research.supportea@aku.edu | |
| Website | http://www.agakhanhospitals.org/nairobi/ |
"ROR" |
https://ror.org/03rppv730 |
Funders
Funder type
Research organisation
Government organisation / National government
- Alternative name(s)
- UKRI
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/02/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this study will be written up as an academic research project and will be submitted for publication within a medical journal. It is likely that the results will also be presented at academic meetings or conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Anoop Shah (Anoop.shah@lshtm.ac.uk). Type of data: baseline characteristics, analysed imaging data, and biochemical data. When the data will become available and for how long: following publication and in perpetuity. By what access criteria data will be shared including with whom, for what types of analyses, and by what mechanism: For secondary analysis in collaboration with primary research team and shared via email. Whether consent from participants was obtained: Yes. Comments on data anonymisation: All data is anonymised and identifiable data removed. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Preprint results | non-peer-reviewed protocol in preprint | 01/10/2020 | 17/03/2021 | No | No |
| Protocol article | 08/05/2021 | 11/05/2021 | Yes | No | |
| Results article | 14/09/2022 | 15/09/2022 | Yes | No |
Editorial Notes
15/09/2022: Publication reference added.
11/05/2021: Publication reference added.
17/03/2021: Preprint reference added.
02/02/2021: The recruitment end date and overall trial end date were changed from 01/02/2021 to 01/03/2021.
05/01/2021: The following changes were made to the trial record:
1. The recruitment end date and overall trial end date were changed from 01/01/2021 to 01/02/2021.
2. The intention to publish date was changed from 01/01/2021 to 01/02/2022.
3. IPD sharing statement added.
21/07/2020: Trial’s existence confirmed by the Aga Khan University, Nairobi Institutional Ethics Review Committee (IERC)
