Comparison of the Use of an Outpatient/Mobile MRI Procedure With an Inpatient MRI Procedure in Adult Patients With Known or Suspected Coronary Artery Disease (CAD)
Key facts
- Who runs it
- German Heart Institute
- Where
- Germany1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 250 people, planned
- Started
- 9 Nov 2026
- Expected to end
- 31 Dec 2028
- Type of study
- Observational, 2 groups
- Treatments tested
- Cardiac stress CMR examinations for clinical diagnostic in adult patients with suspected coronary artery disease
- Record updated
- 12 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Adults based one of the following criteria:
- Male or female subjects aged ≥18 years
- Clinical indication for invasive cardiac diagnostic evaluation in patients with suspected or known coronary artery disease (CAD)
- Patient fully responsible and can understand/sign the study from a legal aspect
- Patients who have provided written informed consent to participate in the study and to the processing of their personal data
Who cannot take part
- Contraindication to the cardiac MRI examination (e.g. inability to hold breath; severe claustrophobia, metallic devices such as pace makers)
- Patient refusal to participate
- Any contraindication to perform an Stress-Perfusion MRI exam
- Sensorineural hearing loss and tinnitus
- Known pregnancy or lactation
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Coronary artery disease (CAD) is the clinically relevant manifestation of atherosclerosis affecting the coronary arteries. CAD is associated with an increased risk of morbidity and mortality and typically presents as angina pectoris or dyspnea. Non-invasive imaging techniques are recommended for the diagnosis of CAD. Of particular importance is stress perfusion cardiac magnetic resonance imaging (CMR), which is distinguished from other recommended diagnostic modalities by its high diagnostic accuracy and the absence of exposure of patients and healthcare professionals to ionizing radiation. Consequently, stress perfusion CMR has been assigned a Class I recommendation in international cardiology guidelines.
Read full original descriptionShow less
The aim of this study is to demonstrate the feasibility of transferring the clinical routine workflow for the diagnostic evaluation of patients with suspected coronary artery disease (CAD) from stationary, specialized centers to mobile MRI units.
This will be demonstrated by comparing two groups. In one group, stress CMR examinations will be performed using mobile MRI units, while in the other group, examinations will be conducted in stationary imaging facilities. Participants will be randomly assigned to one of the two groups.
The 2 groups in the trial
- Mobile Setting Group
Adult patients with suspected coronary artery disease will undergo a clinical indicated stress CMR examination in a mobile MRI unit using stress agent Regadenoson and contrast agent gadobutrol. Stress cardiac examination will be performed In accordance with the protocol established in clinical routine practice and consistent with the MRI examinations performed in the stationary setting group.
Treatment: Cardiac stress CMR examinations for clinical diagnostic in adult patients with suspected coronary artery disease
- Stationary Setting Group
Adult patients with suspected coronary artery disease will undergo a clinical indicated stress CMR examination in a stationary MRI unit using stress agent Regadenoson and contrast agent gadobutrol. Stress cardiac examination will be performed In accordance with the protocol established in clinical routine practice.
Treatment: Cardiac stress CMR examinations for clinical diagnostic in adult patients with suspected coronary artery disease
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparison of the Use of an Outpatient/Mobile MRI Procedure With an Inpatient MRI Procedure in Adult Patients With Known or Suspected Coronary Heart Disease in a Randomized Open-label Study
- Record updated
- 12 November 2026