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Trial record 3 of 4 for:    puentmann

IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION (IMPReSSION)

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ClinicalTrials.gov Identifier: NCT04444128
Recruitment Status : Recruiting
First Posted : June 23, 2020
Last Update Posted : June 23, 2020
Sponsor:
Collaborators:
Kerckhoff Klinik
Johannes Gutenberg University Mainz
University Hospital Ulm
Information provided by (Responsible Party):
Valentina Puentmann, Johann Wolfgang Goethe University Hospital

Tracking Information
First Submitted Date June 1, 2020
First Posted Date June 23, 2020
Last Update Posted Date June 23, 2020
Actual Study Start Date November 15, 2016
Estimated Primary Completion Date November 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 22, 2020)
  • All-cause mortality [ Time Frame: 1 year ]
    number of deaths
  • All-cause mortality [ Time Frame: 5 years ]
    number of deaths
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 22, 2020)
  • Heart Failure Outcome [ Time Frame: 1 year and 5 years ]
    Number of participants with events including death due to heart failure and and hospitalisation due to Heart Failure
  • Cardiovascular Outcome [ Time Frame: 1 year and 5 years ]
    Number of participants with death due to myocardial infarction, heart failure, arrhythmia or vascular events (pulmonary embolism, aortic dissection, stroke)
  • Arrhythmia Outcome [ Time Frame: 1 year and 5 years ]
    Number of participants with documented events including sudden cardiac death, appropriate ICD discharge, sustained VT
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION
Official Title IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION
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 and prognostic relationships in apparently healthy subjects with no known heart disease. A further unknown relates to separation between healthy myocardium and the subclinical disease in several groups of patients with suspected cardiac involvement. Examples include patients with systemic inflammatory conditions, as well as patients with a recent COVID-19 infection.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Retention:   Samples With DNA
Description:
Blood samples
Sampling Method Non-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.
Condition
  • Myocarditis
  • Heart Failure
  • Myocardial Fibrosis
Intervention Diagnostic Test: CMR with T1 and T2 mapping
Subjects undergo CMR study with contrast agent (gadobutrol 0.1 mmol/kg): T1 and T2 mapping, volumes, function, strain and LGE is performed.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 22, 2020)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 15, 2026
Estimated Primary Completion Date November 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Able to provide informed consent
  2. 18 years of age and over
  3. Absence of a valid clinical indication for CMR, including active cardiac symptoms and/or known or clinically relevant cardiac disease

Exclusion Criteria:

  • accepted contraindications for a contrast-enhanced CMR study (in line with MRI safety and SmPC for contrast agent)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04444128
Other Study ID Numbers IMPReSSION Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Valentina Puentmann, Johann Wolfgang Goethe University Hospital
Study Sponsor Johann Wolfgang Goethe University Hospital
Collaborators
  • Kerckhoff Klinik
  • Johannes Gutenberg University Mainz
  • University Hospital Ulm
Investigators Not Provided
PRS Account Johann Wolfgang Goethe University Hospital
Verification Date June 2020