Plain English Summary
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 January 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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Shirjel Alam
ORCID ID
http://orcid.org/0000-0002-2099-612X
Contact details
Southmoor Rd
Roundthorn Industrial Estate
Wythenshawe
Manchester
M23 9LT
United Kingdom
+44 (0)161 998 7070
shirjel.alam1@nhs.uk
Type
Scientific
Additional contact
Dr Anoop Shah
ORCID ID
http://orcid.org/0000-0002-2825-3419
Contact details
Room 249
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)7766544156
anoop.shah@lshtm.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
2020/IERC-74
Study information
Scientific title
CardiOvaScular Mechanisms In Covid-19 (COSMIC-19): A multimodality imaging study
Acronym
COSMIC-19 study
Study hypothesis
The mechanisms and pathological sequelae of Covid-19 induced cardiovascular injury can be identified by multi-modality imaging.
Ethics approval
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)
Study design
Single-centre observational cross-sectional multimodality imaging and biomarker study
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.
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
23/03/2020
Overall trial end date
01/01/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant 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
Recruitment start date
29/06/2020
Recruitment end date
01/01/2021
Locations
Countries of recruitment
Kenya
Trial participating centre
Aga Khan University Hospital
3rd Parklands Avenue off Limuru Road
P.O. Box 30270
Nairobi
GPO 00100
Kenya
Sponsor information
Organisation
The Aga Khan University Hospital
Sponsor details
3rd Parklands Avenue
Limuru Road
Nairobi
GPO 00100
Kenya
+254 203662107
research.supportea@aku.edu
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
UK Research and Innovation
Alternative name(s)
UKRI
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
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 statement:
The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
01/01/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list