Condition category
Circulatory System
Date applied
14/07/2020
Date assigned
14/08/2020
Last edited
14/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.agakhanhospitals.org/nairobi/

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

Publication citations

Additional files

Editorial Notes

21/07/2020: Trial’s existence confirmed by the Aga Khan University, Nairobi Institutional Ethics Review Committee (IERC)