Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods

September 22, 2015 updated by: RWTH Aachen University

Intraprocedural Determination of Myocardial Vitality Using Speckle Tracking Echocardiography Compared to Two-time MRI Diagnostics

The investigators will compare myocard vitality diagnostics using 2D-Strain echography and MRI.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Each patient with typical angina pectoris symptoms will get echocardiographic examination during the inclusion phase. If motion disorder of regional left ventricular myocardial wall is detected, patient will get coronary angiography (not study related, caused of typical angina pectoris symptoms and high probability of CHD). If coronary stenosis related to motion disorder is available, patient will be randomized in two groups during coronary angiography.

  • First Group: Patient will get echocardiographic examination during coronary angiography. 2D-Strain Analysis will be performed based on data of this echocardiographic examination. Only when vitality in the contraction impaired segments will be established based on 2D-Strain Analysis, PCI (Percutaneous Coronary Intervention) will be performed.
  • Second Group: Coronary angiography by patient will be canceled. Patients will get viability assessment using MRI(Magnetic resonance imaging) within the next 7 days. When vitality will be established with MRI, patient will get PCI (Percutaneous Coronary Intervention).

In addition, as part of a feasibility analysis, the possibility of a consolidation of data of coronary angiography with the ultrasound images will be researched by first group of patients. The aim is to simplify the visualization of the intraprocedural vitality detection. For this purpose, a position sensor based on electromagnetic fields (EMT) will be used during coronary angiography.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

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
    • NRW
      • Aachen, NRW, Germany, 52074
        • University Hospital Aachen

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

Description

Inclusion Criteria:

  • Typical angina pectoris symptoms
  • Echocardiographic determination of regional motion disfunction of left ventricular wall
  • Establishment of needly treatment of stenosis related to motion disorder based on coronar angiography.
  • Feasibility of MRI-Examination.
  • Patients which are legally competent and which are mentally able to understand the study staff
  • Patients give their written consent

Exclusion Criteria:

  • Allergy against contrast agent
  • Patients with limited renal function(GFR < 60 ml/min)
  • Acute or instable angina pectoris

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MRI-Arm
Myocardial vitality determination based on MRI diagnostics.
Device: MRI scanner
Coronary angiography on patient will be canceled. Patients will get viability assessment using MRI within the next 7 days. When vitality will be established with MRI, patient will get PCI.
Experimental: Echo-Arm
Myocardial vitality determination using echocardiography in combination with 2D-Strain Analysis.
Device: Cardiac ultrasound
Patient will get echocardiographic examination during coronary angiography. 2D-Strain Analysis will be performed based on data of these echocardiographic examination. Only when vitality in the contraction impaired segments will be established based on 2D-Strain Analysis, PCI will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State of health score
Time Frame: 6 month after diagnistics
State of health score will be determinated by all patients for the evaluation of clinical outcomes (using the standardized questionnaire on state of health (SF-36))6 months after clinical diagnostics.
6 month after diagnistics

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular function (ejection function)
Time Frame: 6 month after diagnistics
Left ventricular function (ejection function) by all patients will be determinated 6 month after diagnostics.
6 month after diagnistics
End-diastolic and end-systolic volume.
Time Frame: 6 month after diagnostics
End-diastolic and end-systolic volume will be determined by all patients 6 month after diagnostics
6 month after diagnostics
Capture of Major Adverse Cardiac and Cerebrovascular Events(MACCE)
Time Frame: 18 month after diagnostics
It will be determined, whether all patients suffered any major adverse cardiac and cerebrovascular events (MACCE) inter alia stroke, myocardial infarction, death 18 month after diagnostics
18 month after diagnostics

Collaborators and Investigators

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

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Michael Becker, MD, University Hospital, Aachen

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

June 1, 2011

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

August 29, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

September 4, 2013

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-004
  • 00012377 (Other Identifier: DIMDI-Nr.)

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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