International T1 Multicenter Outcome Study (T1Outcome-DE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03749343 |
Recruitment Status :
Recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
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Condition or disease |
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Heart Failure Cardiomyopathies Inflammatory Disease Coronary Artery Disease Chronic Kidney Diseases |
Study Type : | Observational |
Estimated Enrollment : | 8000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | International T1 Multicenter Outcome Study (the German Chapter) |
Actual Study Start Date : | March 1, 2016 |
Estimated Primary Completion Date : | March 1, 2022 |
Estimated Study Completion Date : | February 28, 2024 |
- Survival [ Time Frame: 1 year ]number of deaths
- Survival [ Time Frame: 5 year ]number of deaths
- Rate of Heart Failure events [ Time Frame: 1 year ]Number of participants with events including death and Hospitalisation due to Heart Failure
- Rate of Heart Failure events [ Time Frame: 5 year ]Number of participants with events including death and Hospitalisation due to Heart Failure
- Rate of Arrhythmia [ Time Frame: 1 year ]Number of participants with events of documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT
- Rate of Arrhythmia [ Time Frame: 5 year ]Number of participants with events including documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT
- Rate of death due to to cardiovascular causes [ Time Frame: 1 year ]Number of participants with death due to myocardial infarction, heart failure, arrhythmia
- Rate of death due to to cardiovascular causes [ Time Frame: 5 year ]Number of participants with death due to myocardial infarction, heart failure, arrhythmia
Biospecimen Retention: None Retained

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Adults (>18 years of age)
- Able to provide informed consent
- Clinically indicated cardiac magnetic resonance imaging study
Exclusion Criteria: contraindications for clinical cardiac magnetic resonance imaging due to MR unsafe devices or objects

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749343
Contact: Valentina O Puentmann, MD, PhD | cvi-research@kgu.de | ||
Contact: Franziska Weis | cvi-research@kgu.de |
Germany | |
Kerckhoff Hospital | Recruiting |
Bad Nauheim, Hessen, Germany, 61231 | |
Contact: Andreas Rolf | |
Institute for experimental and translational cardiovascular imaging | Recruiting |
Frankfurt Am Main, Hessen, Germany, 60596 | |
Contact: Valentina Puentmann, MD, PhD cvi-research@kgu.de | |
Contact: Franziska Weis cvi-research@kgu.de | |
Sub-Investigator: Eike Nagel, MD, PhD | |
University Hospital Mainz | Recruiting |
Mainz, Hessen, Germany, 55131 | |
Contact: Tilman Emrich, MD |
Principal Investigator: | Valentina Puentmann, MD, PhD | University Hospital, Frankfurt |
Responsible Party: | Valentina Puentmann, Principal Investigator, Clinical professor, Johann Wolfgang Goethe University Hospital |
ClinicalTrials.gov Identifier: | NCT03749343 |
Other Study ID Numbers: |
T1 Outcome 1/16gA |
First Posted: | November 21, 2018 Key Record Dates |
Last Update Posted: | November 21, 2018 |
Last Verified: | November 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
T1 mapping native T1 native T2 accuracy prognosis |
Kidney Diseases Renal Insufficiency, Chronic Coronary Artery Disease Cardiomyopathies Heart Diseases Cardiovascular Diseases Urologic Diseases |
Coronary Disease Myocardial Ischemia Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Renal Insufficiency |