Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01934699
First received: August 29, 2013
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Angina Pectoris
Left Ventricular Wall Motion Abnormalities
Device: Cardiac ultrasound
Device: MRI scanner

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Intraprocedural Determination of Myocardial Vitality Using Speckle Tracking Echocardiography Compared to Two-time MRI Diagnostics

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • State of health score [ Time Frame: 6 month after diagnistics ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 6 month after diagnistics ] [ Designated as safety issue: Yes ]
    Left ventricular function (ejection function) by all patients will be determinated 6 month after diagnostics.

  • End-diastolic and end-systolic volume. [ Time Frame: 6 month after diagnostics ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 18 month after diagnostics ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 170
Study Start Date: June 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01934699

Contacts
Contact: Michael Becker, MD 004924180 ext 80092
Contact: Margarita Gritzewski mgritzewski@ukaachen.de

Locations
Germany
University Hospital Aachen Recruiting
Aachen, NRW, Germany, 52074
Contact: Margarita Gritzewski    004924180 ext 80092    mgritzewski@ukaachen.de   
Principal Investigator: Michael Becker, MD         
Sub-Investigator: Mohammad Almalla, MD         
Sub-Investigator: Ertunc Altiok, MD         
Sub-Investigator: Alexander Schuh, MD         
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Michael Becker, MD University Hospital, Aachen
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01934699     History of Changes
Other Study ID Numbers: 10-004, 00012377
Study First Received: August 29, 2013
Last Updated: April 29, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
Coronary stenosis
Angina pectoris
Left ventricular wall motion abnormalities
2D-Strain

Additional relevant MeSH terms:
Angina Pectoris
Congenital Abnormalities
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014