Hybrid Intraprocedural Imaging Based on 2 Different Imaging Methods

NCT01389674 | Withdrawn

• 3 other identifiers: HIB-StudyCTC-A 08-001EK 079/10
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will check the feasibility of an intraprocedural vitality diagnostics and the identification of an indication for Percutaneous transluminal coronary angioplasty (PTCA).

Conditions

Angina Pectoris; Left Ventricular Wall Motion Abnormalities

Keywords

coronary stenosis; Angina pectoris; left ventricular wall motion abnormalities

Outcome Measures

Primary Outcomes (1)

• Cut-Off-Value of vital myocardial tissue

  It will be determine cutt-off-value of vital myocardial tissue in comparison to MRI myocardial vitality findings.

  time during hospitalization

Secondary Outcomes (2)

• feasibility and safety of echocardiography during catheter investigations

  time during hospitalization and 1 months afterwards

• Determination of Strain-Parameter for identification of vital myocardial tissue

  time during hospitalization

Study Arms (1)

2D-strain echo

EXPERIMENTAL

After myocard vitality diagnostics with MRI follows a stress echocardiography to determine the LV volumes and EF. The received Data are compare with the MRI-Data(reference)to identify the ideal strain-parameters and Cut-Off-Result for an intraprocedural vitality diagnostic of the different films (endocardial, myocardial and epicardial).

Procedure: 2D-strain echo

Interventions

2D-strain echo PROCEDURE

2D-strain-analysis with elevation of the radial and circumferential strain and strain rate parameter(systolic and diastolic)occurs through the echocardiography. Comparison of the echocardiography and the MRI-vitality data, calculation of a cut out of vision value of a vitality diagnosis with the help of 2D-strain-analysis.

2D-strain echo

Eligibility Criteria

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

You may qualify if:

• left ventricular wall motion abnormalities
• existent myocardial vitality MRI exploration
• reduced LV-function
• steady angina pectoris
• 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:

• pregnancy or lactation
• acute or instable angina pectoris
• acute myocardial infraction in the last 3 month

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital Aachen

Aachen, 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

  RWTH Aachen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: July 8, 2011
• Study Start: April 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 9, 2014

Record last verified: 2014-06

Locations

DE (1)