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Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods

Primary Purpose

Angina Pectoris, Left Ventricular Wall Motion Abnormalities

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cardiac ultrasound
MRI scanner
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Angina Pectoris focused on measuring Coronary stenosis, Angina pectoris, Left ventricular wall motion abnormalities, 2D-Strain

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Aachen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

MRI-Arm

Echo-Arm

Arm Description

Myocardial vitality determination based on MRI diagnostics.

Myocardial vitality determination using echocardiography in combination with 2D-Strain Analysis.

Outcomes

Primary Outcome Measures

State of health score
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.

Secondary Outcome Measures

Left ventricular function (ejection function)
Left ventricular function (ejection function) by all patients will be determinated 6 month after diagnostics.
End-diastolic and end-systolic volume.
End-diastolic and end-systolic volume will be determined by all patients 6 month after diagnostics
Capture of Major Adverse Cardiac and Cerebrovascular Events(MACCE)
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

Full Information

First Posted
August 29, 2013
Last Updated
September 22, 2015
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT01934699
Brief Title
Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods
Official Title
Intraprocedural Determination of Myocardial Vitality Using Speckle Tracking Echocardiography Compared to Two-time MRI Diagnostics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Left Ventricular Wall Motion Abnormalities
Keywords
Coronary stenosis, Angina pectoris, Left ventricular wall motion abnormalities, 2D-Strain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI-Arm
Arm Type
Active Comparator
Arm Description
Myocardial vitality determination based on MRI diagnostics.
Arm Title
Echo-Arm
Arm Type
Experimental
Arm Description
Myocardial vitality determination using echocardiography in combination with 2D-Strain Analysis.
Intervention Type
Device
Intervention Name(s)
Cardiac ultrasound
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
MRI scanner
Intervention Description
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.
Primary Outcome Measure Information:
Title
State of health score
Description
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.
Time Frame
6 month after diagnistics
Secondary Outcome Measure Information:
Title
Left ventricular function (ejection function)
Description
Left ventricular function (ejection function) by all patients will be determinated 6 month after diagnostics.
Time Frame
6 month after diagnistics
Title
End-diastolic and end-systolic volume.
Description
End-diastolic and end-systolic volume will be determined by all patients 6 month after diagnostics
Time Frame
6 month after diagnostics
Title
Capture of Major Adverse Cardiac and Cerebrovascular Events(MACCE)
Description
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
Time Frame
18 month after diagnostics

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Becker, MD
Organizational Affiliation
University Hospital, Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Aachen
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

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Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods

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