Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods

Angina Pectoris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01934699
• Other study ID #: 10-004
• Secondary ID: 00012377
• Status: Active, not recruiting
• Phase: N/A
• First received: August 29, 2013
• Last updated: September 22, 2015
• Start date: June 2011
• Est. completion date: July 2016

Study information

• Verified date: September 2015
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Angina Pectoris
• Congenital Abnormalities
• Left Ventricular Wall Motion Abnormalities

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	University Hospital Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 month after diagnistics	Yes
Secondary	Left ventricular function (ejection function)	Left ventricular function (ejection function) by all patients will be determinated 6 month after diagnostics.	6 month after diagnistics	Yes
Secondary	End-diastolic and end-systolic volume.	End-diastolic and end-systolic volume will be determined by all patients 6 month after diagnostics	6 month after diagnostics	Yes
Secondary	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	18 month after diagnostics	Yes