Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods

NCT01934699 | Unknown

• 2 other identifiers: 10-00400012377
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Angina Pectoris; Left Ventricular Wall Motion Abnormalities

Keywords

Coronary stenosis; Angina pectoris; Left ventricular wall motion abnormalities; 2D-Strain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Left ventricular function (ejection function)

  6 month after diagnistics

• End-diastolic and end-systolic volume.

  6 month after diagnostics

• Capture of Major Adverse Cardiac and Cerebrovascular Events(MACCE)

  18 month after diagnostics

Study Arms (2)

MRI-Arm

ACTIVE COMPARATOR

Myocardial vitality determination based on MRI diagnostics.

Device: MRI scanner

Echo-Arm

EXPERIMENTAL

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

Device: Cardiac ultrasound

Interventions

Cardiac ultrasound DEVICE

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.

Echo-Arm

MRI scanner DEVICE

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.

MRI-Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Angina Pectoris; Coronary Stenosis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease

Study Officials

• Michael Becker, MD

  University Hospital, Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 4, 2013
• Study Start: June 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

DE (1)