Differences in the quantity of fluid detected in pleural and pericardial space by cardiovascular magnetic resonance between healthy subjects and subjects with inflammatory heart disease

Prevalence and characteristics of pleural and pericardial fluid in subjects with and without myocardial inflammation as detected using cardiovascular magnetic resonance imaging

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN24808788

Enrollment

300

Registered

2019-08-28

Start date

2016-02-03

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial inflammatory disease Circulatory System

Interventions

1. Cardiac MRI scan to detect myocardial inflammation at the beginning of the study (with contrast media for patients, without contrast media for healthy subjects), second cardiac MRI scan for female

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with suspected inflammatory heart disease: Clinical indication for MR exam with late gadolinium enhancement 2. Healthy premenopausal women: MR exam without contrast media

Exclusion criteria

Exclusion criteria: 1. Any contraindication for MR exam 2. Any known pericardial or pleural disease 3. Any known malignant disease in the last 5 years 4. Pregnancy

Design outcomes

Primary

Measure	Time frame
1. Presence of pleural and pericardial fluid deposits assessed using cardiac MRI scan at the baseline examination 2. Markers of inflammation measured using laboratory tests (WBC and c-reactive protein, hs-troponin) and MRI (standard parameters of myocardial inflammation: edema, late and early gadolinium enhancement) at baseline	—

Secondary

Measure	Time frame
1. Presence of pleural and pericardial fluid deposits assessed using cardiac MRI scan in subjects without any sign of inflammation and in healthy subjects at baseline and in accordance to the phase of the menstrual cycle 2. The amount (measured in mililiters) of pleural and pericardial fluid detected by MRI in premenopausal women in different (follicular or luteal) phases of the menstrual cycle 3. Quantification (in milliliters) of small amounts of pleural and pericardial fluid by semiautomated threshold method in MRI DICOM data at luteal and follicular phase of menstrual cycle 4. Development of heart failure, hospitalizations for cardiovascular reasons, death, assessed using standard questionnaire form up to 5 years	—

Measure

Time frame

1. Presence of pleural and pericardial fluid deposits assessed using cardiac MRI scan in subjects without any sign of inflammation and in healthy subjects at baseline and in accordance to the phase of the menstrual cycle 2. The amount (measured in mililiters) of pleural and pericardial fluid detected by MRI in premenopausal women in different (follicular or luteal) phases of the menstrual cycle 3. Quantification (in milliliters) of small amounts of pleural and pericardial fluid by semiautomated threshold method in MRI DICOM data at luteal and follicular phase of menstrual cycle 4. Development of heart failure, hospitalizations for cardiovascular reasons, death, assessed using standard questionnaire form up to 5 years

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026