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)
A legfontosabb adatok
- Ki végzi
- German Heart Institute
- Hol
- Németország1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toborzás még nem indult
- Résztvevők
- 250 fő, tervezett
- Kezdés
- 2026. nov. 9.
- Várható befejezés
- 2028. dec. 31.
- A vizsgálat típusa
- Megfigyeléses, 2 csoport
- A vizsgált kezelések
- Cardiac stress CMR examinations for clinical diagnostic in adult patients with suspected coronary artery disease
- A regiszteradat frissítve
- 2026. november 12.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 10 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- 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.
Kezelés: 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.
Kezelés: Cardiac stress CMR examinations for clinical diagnostic in adult patients with suspected coronary artery disease
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- 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
- A regiszteradat frissítve
- 2026. november 12.