Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT00549861
Eligibility Criteria:
Inclusion Criteria:
* Known cardiomyopathy (DCM, HCM, ARVC or LVNC)
* Clinical indication for contrast-enhanced Cardiac Magnetic Resonance study
* Ability to give informed consent
Exclusion Criteria:
* Any contraindication for a Magnetic Resonance Study including implanted devices, claustrophobia etc.
* Allergic reaction to Gadolinium-based contrast agents
* Known adverse reaction to Gadovist®
* Inability to give informed consent
* Known long-QT syndrome or other known conduction abnormalities
* Pregnancy or breast-feeding
* Any exclusion criteria for the administration of Gadovist® as stated in the product monograph for Warning and Precautions, e.g. Hx of allergic dispositions, or bronchial asthma; sickle cell anemia or hemoglobinopathies; renal insufficiency, with hypokalemia; convulsive states
* Conditions and concomitant medication which may prolong the QTc interval, e.g. long-QT syndrome, patients with hypokalemia, receiving Class I1 (e.g. quinidine, procainamide) or class III (amiodarone, sotalol) known antiarrhythmogenic drugs, or other medication that are known to prolong QT interval (such as cisapride, erythromycin, antipsychotic and antidepressants) - since there is a lack of clinical experience and potential risks with the concomitant use of these medication with the MRI contrast
* Patients with severe renal impairment (GFR \<30mL/min)
* Patients with previous reaction to MRI and / or CT contrast media
* Patients with acute renal dysfunction due to hepato-renal syndrome or patients in the perioperative liver transplantation period
* Patients with end-stage renal disease (GFR \<15mL/min/1.73m2)
* Unstable patients, e.g. from CCU / ICU
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00549861
Study Brief:
Protocol Section:
NCT00549861