MRI Perfusion Imaging at 3Tx Compared to Invasive FFR Measurements

NCT01277055 | Unknown

• 1 other identifier: HCB10071
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with intermediate lesion who underwent cardiac catheterization inluding measurement of the myocardial fractional flow reserve

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Heart Center Bogenhausen: lead

Study Sites (1)

Heart Center Bogenhausen, Munich Municipal Hospital Group

Munich, Bavaria, 81925, Germany

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 14, 2011
• Study Start: January 1, 2011
• Last Updated: January 14, 2011

Record last verified: 2011-01

Locations

DE (1)