MRI Perfusion Imaging at 3Tx Compared to Invasive FFR Measurements

Myocardial Ischemia Clinical Trial

— Vision MRT  

Official title:

MRI Perfusion Imaging at 3T With TX Parallel RF Technology to Identify Myocardial Ischemia Compared to Invasive FFR Measurements

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01277055
• Other study ID #: HCB10071
• Status: Recruiting
• Phase: N/A
• First received: January 13, 2011
• Last updated: January 13, 2011
• Start date: January 2011

Study information

• Verified date: January 2011
• Source: Heart Center Bogenhausen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: The Bavarian State Ministry of the Environment and Public Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• MRI
• Myocardial Fractional Flow Reserve
• Myocardial Ischemia
• Perfusion Imaging

Locations

Country	Name	City	State
Germany	Heart Center Bogenhausen, Munich Municipal Hospital Group	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Heart Center Bogenhausen

Country where clinical trial is conducted

Germany,