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Vision MRT: MRI Perfusion Imaging at 3Tx Compared to Invasive FFR Measurements

Sponsor
Heart Center Bogenhausen (Other)
Overall Status
Unknown status
CT.gov ID
NCT01277055
Collaborator
(none)
150
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    MRI Perfusion Imaging at 3T With TX Parallel RF Technology to Identify Myocardial Ischemia Compared to Invasive FFR Measurements
    Study Start Date :
    Jan 1, 2011

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 90 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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)

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Heart Center Bogenhausen, Munich Municipal Hospital Group Munich Bavaria Germany 81925

      Sponsors and Collaborators

      • Heart Center Bogenhausen

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01277055
      Other Study ID Numbers:
      • HCB10071
      First Posted:
      Jan 14, 2011
      Last Update Posted:
      Jan 14, 2011
      Last Verified:
      Jan 1, 2011
      Additional relevant MeSH terms:
      Myocardial Ischemia
      Coronary Artery Disease
      Ischemia

      Study Results

      No Results Posted as of Jan 14, 2011