MRI Perfusion Imaging at 3Tx Compared to Invasive FFR Measurements

NCT ID: NCT01277055

Last Updated: 2011-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31

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.

Conditions

Perfusion Imaging; MRI; Myocardial Fractional Flow Reserve; Myocardial Ischemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart Center Bogenhausen

OTHER

Sponsor Role: lead

Responsible Party

Heart Center Bogenhausen

Locations

Heart Center Bogenhausen, Munich Municipal Hospital Group

Munich, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Facility Contacts

Ullrich Ebersberger, MD

Role: primary

ebersberger@gmx.net

0049-89-9270-91 ext. 2634

Alexander Leber, MD

Role: backup

dr_leber@gmx.de

0049-89-9270-91 ext. 2773

Other Identifiers

HCB10071

Identifier Type: -

Identifier Source: org_study_id