MRI Perfusion Imaging at 3Tx Compared to Invasive FFR Measurements

• Conditions: Perfusion Imaging; Myocardial Fractional Flow Reserve; Myocardial Ischemia; MRI

• Registration Number: NCT01277055
• Lead Sponsor: Heart Center Bogenhausen

Brief Summary

Coronary artery disease (CAD) has a great significance concerning prevalence and mortality in the western world. It is usually diagnosed by catheterization and coronary arteries are visually assessed by the examiner. Thus having a great spectrum of interobserver differences, especially when it comes to intermediate lesions. The gold standard to assess the haemodynamic significance is the measurement of the myocardial fractional flow reserve (FFR). The FAME-study (Tonino, De Bruyne et al. 2009) was able o show that additional FFR- measurements in patients with intermediate lesions could significantly reduce stent implementation and consequently mortality. However this method is not used in daily routine and is available only in a fraction of catheter labs worldwide. Taking this into account decision finding especially in intermediate lesions remains difficult.

One major step to simplify the invasive approach concerning intermediate lesions would be to establish a non-invasive procedures which localizes the coronary vessel to intervene ahead catheterization.

Do to steady technical development cardiac MRI has become a powerful tool which is able to determine myocardial vitality, perfusion and function. In particular the new generation of 3 Tesla multi transmit MR with its higher field strength and better spatial resolution seems to be able to show first pass myocardial perfusion more precise. With this new technology prefixed to cardiac catheterization clinical relevant information can be made accessible and thus reduce the number of unnecessary implemented stents.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-01
• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-13
• Last Update Submitted: 2011-01-13
• Study First Posted: 2011-01-14
• Last Update Posted: 2011-01-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• intermediate lesion defined by myocardial fractional flow reserve measurement
• age > 18 years

Exclusion Criteria

• pregnancy
• contraindication with adenosin, contrast agents or MR-Scaning
• severe renal dysfunktion
• instable patient(e.g. acute myocardial infarction)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Heart Center Bogenhausen, Munich Municipal Hospital Group; 🇩🇪 Munich, Bavaria, Germany