NCT04444128

Brief Summary

Magnetic properties of myocardial tissue change in the presence of disease. This is detectable in the change of rate of magnetic relaxation, and measurable by T1 and T2 mapping using cardiovascular magnetic resonance (CMR). These markers provide novel quantifiable imaging measures for myocardial tissue characterisation. Despite similar principles, the measurements differ considerably between different sequences, vendors and field strengths, yielding a necessity to establish robust sequence-specific normal ranges, diagnostic accuracy, relationships with clinical characteristics, cardiovascular risk factors, routine cardiac imaging parameters, and prognosis. A further unknown relates to separation between healthy myocardium and subclinical disease in subgroups of patients with suspected cardiac involvement. Examples include patients with possible inflammation, such as in patients with a recent COVID-19 infection or vaccination. Anticipated recruitment of a total of 3000 subjects, with 1500 subjects per field strength (1.5 and 3.0 Tesla).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
51mo left

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Nov 2016Jun 2030

Study Start

First participant enrolled

November 15, 2016

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

13.6 years

First QC Date

June 1, 2020

Last Update Submit

January 2, 2026

Conditions

MyocarditisHeart FailureMyocardial FibrosisVascular InflammationLong COVID Syndrome

Keywords

InflammationRemodelingvascular inflammation

Outcome Measures

Primary Outcomes (2)

  • All-cause mortality

    number of deaths

    1 year

  • All-cause mortality

    number of deaths

    5 years

Secondary Outcomes (3)

  • Heart Failure Outcome

    1 year and 5 years

  • Cardiovascular Outcome

    1 year and 5 years

  • Arrhythmia Outcome

    1 year and 5 years

Interventions

Cardiac ImagingDIAGNOSTIC_TEST

Subjects undergo CMR study with contrast agent (gadobutrol 0.1 mmol/kg; mapping, volumes, function, strain and LGE); transthoracic echocardiography, blood sampling and cardiopulmonary exercise testing.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants are consecutive asymptomatic healthy subjects or patients from subgroups with known high risk (such as a recent COVID19 infection) with no known or clinically relevant cardiac disease or currently prescribed cardiac medication.

You may qualify if:

  • Able to provide informed consent
  • years of age and over
  • Absence of a valid clinical indication for CMR, and/or known or clinically relevant cardiac disease

You may not qualify if:

  • accepted contraindications for a contrast-enhanced CMR study (in line with MRI safety and SmPC for contrast agent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Frankfurt

Frankfurt am Main, Hesse, Frankfurt am Main, Germany

RECRUITING

Related Publications (3)

  • Puntmann VO, Carerj ML, Wieters I, Fahim M, Arendt C, Hoffmann J, Shchendrygina A, Escher F, Vasa-Nicotera M, Zeiher AM, Vehreschild M, Nagel E. Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Nov 1;5(11):1265-1273. doi: 10.1001/jamacardio.2020.3557.

    PMID: 32730619RESULT

  • Puntmann VO, Martin S, Shchendrygina A, Hoffmann J, Ka MM, Giokoglu E, Vanchin B, Holm N, Karyou A, Laux GS, Arendt C, De Leuw P, Zacharowski K, Khodamoradi Y, Vehreschild MJGT, Rohde G, Zeiher AM, Vogl TJ, Schwenke C, Nagel E. Long-term cardiac pathology in individuals with mild initial COVID-19 illness. Nat Med. 2022 Oct;28(10):2117-2123. doi: 10.1038/s41591-022-02000-0. Epub 2022 Sep 5.

    PMID: 36064600RESULT

  • Shchendrygina A, Ka MM, Rodriguez C, Alsoufi S, Hoffmann J, Kumar P, Carerj ML, Vanchin B, Holm N, Karyou A, Ganbat M, Nagel E, Puntmann VO. Subclinical patterns of cardiac involvement by transthoracic echocardiography in individuals with mild initial COVID-19. Sci Rep. 2025 Jan 30;15(1):3772. doi: 10.1038/s41598-025-85221-w.

    PMID: 39885199RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

MyocarditisHeart FailureInflammation

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Valentina O Puentmann

CONTACT

+4969 630184491cvi-studien@unimedizin-ffm.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priv Doz Dr Dr

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 23, 2020

Study Start

November 15, 2016

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)