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

January 13, 2011 updated by: Heart Center Bogenhausen

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81925
        • Recruiting
        • Heart Center Bogenhausen, Munich Municipal Hospital Group
        • Contact:
        • Contact:
          • Alexander Leber, MD
          • Phone Number: 2773 0049-89-9270-91
          • Email: dr_leber@gmx.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Center Bogenhausen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Study Registration Dates

First Submitted

January 13, 2011

First Submitted That Met QC Criteria

January 13, 2011

First Posted (Estimate)

January 14, 2011

Study Record Updates

Last Update Posted (Estimate)

January 14, 2011

Last Update Submitted That Met QC Criteria

January 13, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB10071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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