AzTrials
AzTrials

COVIDCISCO-19NCT04403607

Cardiac Imaging in SARS-CoV-2 (COVID-19)

An observational study of COVID, run by NHS Greater Glasgow and Clyde at 3 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

One-in-four patients with COVID-19 pneumonia develop life-threatening heart problems. Through cardiovascular imaging and biomarkers analyses this study aims to evaluate whether COVID-19 infection results in heart injury. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID
How many people
180 participants
Where
3 sitesUnited Kingdom
Study dates
22 May 2020to May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All-comers who have attended or admitted to hospital for COVID-19 and meet the eligibility criteria described

Who may be able to join

  • History of hospital attendance or hospitalisation for COVID-19, confirmed by a clinical diagnosis, laboratory test e.g. PCR and/or a radiological test e.g. CT chest or chest X-ray
  • Age 18 years or more
  • Capacity to provide written informed consent
  • Able to comply with study procedures

Who cannot join

  • Contra-indication to CMR e.g. severe claustrophobia, metallic foreign body
  • Lack of informed consent
  • Women who are pregnant, breast-feeding or of child-bearing potential without a negative pregnancy test

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

  • Royal Infirmary

    Glasgow, G31 2ER

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Royal Alexandra Hospital

    Paisley, Renfrewshire, PA2 9PJ

Other trials in United Kingdom

About this study

Official title: Cardiovascular and Pulmonary Imaging in SARS-CoV-2: A Study of the Heart, Lungs and Wellbeing After COVID-19.

One-in-four patients with COVID-19 pneumonia develop life-threatening heart problems. Through cardiovascular imaging and biomarkers analyses this study aims to evaluate whether COVID-19 infection results in heart injury. The investigators will also investigate which patients are at risk of heart injury as a result of COVID-19 and why only some patients suffer heart problems as a consequence of the infection. The study will also assess multisystem involvement including the lungs and kidneys.

Read the detailed description

Our study is supported through the Chief Scientist Office Rapid Research in Covid-19 (RARC-19) programme. Our study will clarify the pathogenesis of cardiopulmonary injury, notably endotypes of myocardial injury including myocarditis, in patients with COVID-19.

The study involves a prospective, observational, multicentre, longitudinal cohort design.The investigators aim to minimise selection bias by adopting consecutive screening of all-comers hospitalised with COVID-19 and the eligibility criteria are broad. For example, severe renal dysfunction is not an exclusion criterion. The sample size is 180 patients enrolled at baseline with 160 attending for the primary outcome evaluation (cardiac imaging) at 28 days post-discharge. The investigators will use advanced cardiovascular imaging to identify the number (proportion) of patients with myocardial inflammation (myocarditis) that is sub-clinical (i.e. not diagnosed) or clinically overt. Cardiovascular MRI and CT coronary angiography will provide a comprehensive examination one month after discharge is intended to detect persisting cardiovascular complications and diagnose clinical endotypes. The investigators aim to clarify the pathological significance of serial changes in circulating troponin, NTproBNP and renal function. By correlating the MRI findings with troponin I and other measures of cardiovascular injury, such as NTproBNP, our results will inform care pathways that use these blood tests to guide the management of patients with COVID-19. Correlation of imaging findings with baseline clinical information, biomarkers, patient reported outcome measures and well-being in the longer term will help to clarify the clinical significance of cardiovascular complications in COVID-19. Since the design is observational, an interim analysis may be undertaken with the timing informed by the enrolment rate.

Longer term follow-up will include a 5-year visit, contingent on funding and ethics approval, and electronic health record linkage of vital status and episodes of NHS care.

Conditions
COVID

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04403607
Study groupRoleWhat they receive
COVID-19Patients with confirmed COVID-19 meeting the eligibility criteria specified in the protocol.
ControlCOVID-19 negative. Age/sex matched to the COVID-19 cohort. Age range 40-80 years. At least one cardiovascular risk factor by ASSIGN criteria.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary cardiac outcome is the proportion of patients with a diagnosis of myocardial inflammation (myocarditis).

    Myocardial inflammation (or myocarditis) will be revealed by cardiovascular magnetic resonance imaging (MRI) according to contemporary guidelines including the modified Lake Louise Criteria. The endotypes of myocardial injury are 1) myocardial inflammation due to 1.1) viral myocarditis, 1.2) ischaemia, or 1.3) stress (Takotsubo) cardiomyopathy, 2) myocardial infarction, 3) indeterminate, or 4) none. The final diagnosis will be a consensus-based determination by an expert panel. This information will provide insights into the incidence, nature, time-course and clinical significance of cardiovascular involvement in patients with COVID-19. The clinical significance of our findings will be assessed through associations with patient reported outcome measures (PROMS) and health outcomes in the longer term.

    Measured: 28 days after discharge from hospital

  2. The primary cardio-pulmonary outcome is the proportion of patients with thrombosis

    Thrombosis of the right heart, pulmonary arteries and left heart will be determined contrast-enhanced CT chest, angiography and MRI.

    Measured: 28 days after discharge from hospital

Secondary outcomes (13)

  1. Myocardial injury

    Assess mechanisms using circulating biomarkers of cardiac injury, high sensitivity troponin I (ng/L) and its change over time from baseline.

    Measured: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)

  2. Myocardial stress

    Assess the significance of myocardial injury by measuring circulating concentrations of NTproBNP (pg/mL) and its change over time from baseline.

    Measured: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)

  3. Systemic inflammation

    Assess systemic inflammation by measurement of the peak circulating concentration of C-reactive protein (mg/dL) and its change over time.

    Measured: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)

  4. Vascular injury

    Assess vascular injury/inflammation by measurement of the peak circulating concentration of IL-6 (pg/mL) and its change over time.

    Measured: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)

  5. Endothelial activation and haemostasis

    Assess endothelial injury by immunoassay measurement of the peak circulating concentration of VWF:ag (IU/dL) and its change over time. Other measures of haemostasis will also be measured.

    Measured: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)

  6. Fibrin lysis

    Assess fibrin lysis by measurement of the peak circulating concentration of fibrin D-dimer (IU/dL) and its change over time.

    Measured: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)

  7. Coagulation

    Assess coagulation by measurement of Activated Partial Thromboplastin Time (APTT) in seconds. Other measures of coagulation will also be measured.

    Measured: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)

  8. Platelet count

    Assess platelet count (n/microlitre), minimum value (thrombocytopaenia) and change over time.

    Measured: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)

  9. Renal function

    Assess renal function using urine albumin:creatinine ratio and its change over time. Other measures of renal function/injury will also be assessed.

    Measured: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)

  10. Quantify myocardial perfusion as a measure of coronary microvascular function

    Stress perfusion MRI will provide quantitative assessments of myocardial perfusion (ml/min/g) and classify perfusion abnormalities according to other MRI findings e.g. scar, inflammation and coronary artery disease as revealed by CT coronary angiography.

    Measured: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)

  11. Association of the primary outcome according to a prior history of cardiovascular disease or no history of prior cardiovascular disease.

    Imaging for coronary disease, PTE and lung pathology will be correlated with NHS clinical data on prior history of cardiovascular disease.

    Measured: 28 days after discharge from hospital, > 1 year post discharge (average 18-22 months)

  12. Patient reported outcome measures (PROMS) - health status

    Health status, well being and function will be prospectively assessed using prespecified PROMS : EuroQOL EQ-5D-5L score. Other measures of health status will also be assessed.

    Measured: 1 year

  13. PROMS - functional capacity

    Patient reported functional activity using the Duke Activity Status Index (DASI), measured by the score generated from the questionnaire (https://www.mdcalc.com/duke-activity-status-index-dasi)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2020
  2. Study start22 May 2020
  3. Primary completion18 Mar 2021
  4. Study completionMay 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04403607
Sponsor's protocol ID
GN20ID164
Acronym
CISCO-19
Status last verified
Mar 2022
First submitted
20 May 2020
Last updated
3 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Guzik TJ, Mohiddin SA, Dimarco A, Patel V, Savvatis K, Marelli-Berg FM, Madhur MS, Tomaszewski M, Maffia P, D'Acquisto F, Nicklin SA, Marian AJ, Nosalski R, Murray EC, Guzik B, Berry C, Touyz RM, Kreutz R, Wang DW, Bhella D, Sagliocco O, Crea F, Thomson EC, McInnes IB. COVID-19 and the cardiovascular system: implications for risk assessment, diagnosis, and treatment options. Cardiovasc Res. 2020 Aug 1;116(10):1666-1687. doi: 10.1093/cvr/cvaa106.

    PubMed 32352535

  • Cosyns B, Lochy S, Luchian ML, Gimelli A, Pontone G, Allard SD, de Mey J, Rosseel P, Dweck M, Petersen SE, Edvardsen T. The role of cardiovascular imaging for myocardial injury in hospitalized COVID-19 patients. Eur Heart J Cardiovasc Imaging. 2020 Jul 1;21(7):709-714. doi: 10.1093/ehjci/jeaa136.

    PubMed 32391912

  • Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Helio T, Heymans S, Jahns R, Klingel K, Linhart A, Maisch B, McKenna W, Mogensen J, Pinto YM, Ristic A, Schultheiss HP, Seggewiss H, Tavazzi L, Thiene G, Yilmaz A, Charron P, Elliott PM; European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013 Sep;34(33):2636-48, 2648a-2648d. doi: 10.1093/eurheartj/eht210. Epub 2013 Jul 3.

    PubMed 23824828

  • Ferreira VM, Schulz-Menger J, Holmvang G, Kramer CM, Carbone I, Sechtem U, Kindermann I, Gutberlet M, Cooper LT, Liu P, Friedrich MG. Cardiovascular Magnetic Resonance in Nonischemic Myocardial Inflammation: Expert Recommendations. J Am Coll Cardiol. 2018 Dec 18;72(24):3158-3176. doi: 10.1016/j.jacc.2018.09.072.

    PubMed 30545455

  • Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.

    PubMed 30571511

  • Kamdar A, Morrow AJ, Sykes R, McIntosh A, Bagot C, Bayes HK, Blyth KG, Church C, Gillespie L, Roditi G, Stobo D, Weeden S, Welsh P, Mangion K, McConnachie A, Berry C; CISCO-19 Consortium. Illness trajectory in the longer term after hospitalisation for COVID-19: a prospective, multicentre cohort study. BMC Infect Dis. 2026 Jan 20;26(1):344. doi: 10.1186/s12879-025-12487-w.

    PubMed 41559637

  • Sykes R, Morrow AJ, Mangion K, McConnachie A, McIntosh A, Roditi G, Peng L, Rooney C, Scott K, Stobo DB, Berry C, Church C, Bayes H; CISCO-19 investigators. Radiological abnormalities persist following COVID-19 and correlate with impaired health-related quality of life: a prospective cohort study of hospitalised patients. BMJ Open Respir Res. 2025 Feb 10;12(1):e001985. doi: 10.1136/bmjresp-2023-001985.

    PubMed 39929549

  • Sykes RA, Neves KB, Alves-Lopes R, Caputo I, Fallon K, Jamieson NB, Kamdar A, Legrini A, Leslie H, McIntosh A, McConnachie A, Morrow A, McFarlane RW, Mangion K, McAbney J, Montezano AC, Touyz RM, Wood C, Berry C. Vascular mechanisms of post-COVID-19 conditions: Rho-kinase is a novel target for therapy. Eur Heart J Cardiovasc Pharmacother. 2023 Jun 2;9(4):371-386. doi: 10.1093/ehjcvp/pvad025.

    PubMed 37019821

  • Sykes R, Morrow AJ, McConnachie A, Kamdar A, Bagot C, Bayes H, Blyth KG, Briscoe M, Bulluck H, Carrick D, Church C, Corcoran D, Delles C, Findlay I, Gibson VB, Gillespie L, Grieve D, Barrientos PH, Ho A, Lang NN, Lowe DJ, Lennie V, MacFarlane P, Mayne KJ, Mark P, McIntosh A, McGeoch R, McGinley C, Mckee C, Nordin S, Payne A, Rankin A, Robertson KE, Ryan N, Roditi GH, Sattar N, Stobo DB, Allwood-Spiers S, Touyz R, Veldtman G, Weeden S, Watkins S, Welsh P, Wereski R, Mangion K, Berry C. Adjudicated myocarditis and multisystem illness trajectory in healthcare workers post-COVID-19. Open Heart. 2023 Feb;10(1):e002192. doi: 10.1136/openhrt-2022-002192.

    PubMed 36822817

  • Morrow AJ, Sykes R, McIntosh A, Kamdar A, Bagot C, Bayes HK, Blyth KG, Briscoe M, Bulluck H, Carrick D, Church C, Corcoran D, Findlay I, Gibson VB, Gillespie L, Grieve D, Hall Barrientos P, Ho A, Lang NN, Lennie V, Lowe DJ, Macfarlane PW, Mark PB, Mayne KJ, McConnachie A, McGeoch R, McGinley C, McKee C, Nordin S, Payne A, Rankin AJ, Robertson KE, Roditi G, Ryan N, Sattar N, Allwood-Spiers S, Stobo D, Touyz RM, Veldtman G, Watkins S, Weeden S, Weir RA, Welsh P, Wereski R; CISCO-19 Consortium; Mangion K, Berry C. A multisystem, cardio-renal investigation of post-COVID-19 illness. Nat Med. 2022 Jun;28(6):1303-1313. doi: 10.1038/s41591-022-01837-9. Epub 2022 May 23.

    PubMed 35606551

  • Mangion K, Morrow A, Bagot C, Bayes H, Blyth KG, Church C, Corcoran D, Delles C, Gillespie L, Grieve D, Ho A, Kean S, Lang NN, Lennie V, Lowe DJ, Kellman P, Macfarlane PW, McConnachie A, Roditi G, Sykes R, Touyz RM, Sattar N, Wereski R, Wright S, Berry C. The Chief Scientist Office Cardiovascular and Pulmonary Imaging in SARS Coronavirus disease-19 (CISCO-19) study. Cardiovasc Res. 2020 Dec 1;116(14):2185-2196. doi: 10.1093/cvr/cvaa209.

    PubMed 32702087

Questions about this trial

What is this clinical trial studying?

An observational study of COVID, run by NHS Greater Glasgow and Clyde at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary cardiac outcome is the proportion of patients with a diagnosis of myocardial inflammation (myocarditis). (time frame: 28 days after discharge from hospital). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04403607, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022; AzTrials last refreshed its copy on 3 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in