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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Heart Center Bogenhausen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01277055
First Posted: January 14, 2011
Last Update Posted: January 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heart Center Bogenhausen
  Purpose

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
Perfusion Imaging MRI Myocardial Fractional Flow Reserve Myocardial Ischemia

Study Type: Observational
Study Design: 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

Further study details as provided by Heart Center Bogenhausen:

Estimated Enrollment: 150
Study Start Date: January 2011
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with intermediate lesion who underwent cardiac catheterization inluding measurement of the myocardial fractional flow reserve
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277055


Locations
Germany
Heart Center Bogenhausen, Munich Municipal Hospital Group Recruiting
Munich, Bavaria, Germany, 81925
Contact: Ullrich Ebersberger, MD    0049-89-9270-91 ext 2634    ebersberger@gmx.net   
Contact: Alexander Leber, MD    0049-89-9270-91 ext 2773    dr_leber@gmx.de   
Sponsors and Collaborators
Heart Center Bogenhausen
  More Information

Responsible Party: Alexander Leber, MD, Heart Center Bogenhausen
ClinicalTrials.gov Identifier: NCT01277055     History of Changes
Other Study ID Numbers: HCB10071
First Submitted: January 13, 2011
First Posted: January 14, 2011
Last Update Posted: January 14, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases