Assessing Myocardial Blood Flow and Blood Flow Reserve by Transoesophageal Echocardiography (TEE)

This study has been withdrawn prior to enrollment.
(echo contrast agents no longer allowed in CAD patients.)
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00286559
First received: February 2, 2006
Last updated: June 30, 2010
Last verified: June 2010
  Purpose

Until today it was not possible to reliably assess the function of a new bypass, i.e., to measure myocardial perfusion. Measuring intramyocardial blood flow directly after revascularisation would greatly improve the assessment of graft function. With transthoracic contrast echocardiography, myocardial perfusion can be reliably assessed, as it has been shown in numerous studies. In the first part of the study the investigators will clarify methodological aspects of contrast echocardiography. In the second part they will analyze the validity of contrast TEE in the operating room.


Condition Intervention Phase
Coronary Artery Disease
Drug: SonoVue
Drug: Optison
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Feasibility and Accuracy of Transoesophageal Harmonic Contrast Echocardiography in Assessing Myocardial Blood Flow and Blood Flow Reserve

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • coronary bypass graft patency [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • long-term survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2006
Estimated Study Completion Date: December 2008
Detailed Description:

Until today it was not possible to reliably assess the function of a new bypass, i.e., to measure myocardial perfusion. Measuring intramyocardial blood flow directly after revascularisation would greatly improve the assessment of graft function. With transthoracic contrast echocardiography myocardial perfusion can be reliably assessed, as it has been shown in numerous studies.

As there is a new transoesophageal ultrasound probe on the market which allows contrast imaging, we would like to establish contrast echocardiography in the operating room in patients undergoing CABG surgery.

Ultrasound contrast agents (e.g., SonoVue®, Optison®) consist of gas filled microspheres surrounded by a stabilizing coat. They are smaller than red blood cells and similar to blood in their rheological habit. The microspheres are injected into a peripheral or central vein. They pass lung circulation and disperse into the left heart, coronary arteries and body circulation. A few minutes after administration the low-soluble gas of the microspheres is exhaled. The interaction of the ultrasound beam with microspheres leads to oscillation of the microspheres and thereby amplification of the ultrasound signal. This technique allows enhancement of endocardial border but also visualization of myocardial perfusion and assessment of myocardial blood flow reserve. The latter requires measurement of myocardial perfusion a first time at rest and a second time during hyperemia with adenosine. The quotient of both gives myocardial flow reserve. This parameter is of paramount importance in cardiology to detect coronary artery stenosis and reduced coronary or myocardial flow reserve quantitatively.

The contrast agents as well as adenosine (a natural purine nucleoside, which can be found in all cells of the body) have a good safety profile with harmless and transient side effects. Our patients will be under anesthesia and therefore feel none of those side effects.

The study will be spread into two parts. In a first part we will clarify methodological aspects of contrast echocardiography: two different contrast agents and three different contrast imaging methods will be evaluated. One imaging method and one contrast agent will be chosen for the second part. In the second part we will analyze the validity of contrast TEE in the operating room. In addition correlation of changes in myocardial blood flow after coronary artery bypass graft (CABG) surgery and improvement in myocardial perfusion as well as global and regional function in follow-up SPECT (Single Photon Emission Computed Tomography) and transthoracic echocardiography, respectively will be evaluated. By means of these data we possibly will be able to predict success of revascularisation at the end of surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Part I: Patients with angiographically normal coronary vessels undergoing elective valve surgery or patients with coronary artery disease (CAD) who are planned for elective CABG surgery
  • Part II: Patients with CAD who are planned for elective CABG surgery and who had SPECT including adenosine for hyperemia before surgery

Exclusion Criteria:

  • No consent
  • Acute coronary syndrome
  • Acute heart failure
  • Left ventricular ejection fraction < 30%
  • Pronounced pulmonary artery hypertension
  • Known adverse reaction against Optison or SonoVue or their components
  • Severe renal or hepatic insufficiency
  • Severe obstructive lung disease
  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: NCT00286559

Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Manfred D Seeberger, Prof. Dr. University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: Prof. Dr. M. Seeberger, Head of Cardiothoracic Anesthesia, -
ClinicalTrials.gov Identifier: NCT00286559     History of Changes
Other Study ID Numbers: 50/05
Study First Received: February 2, 2006
Last Updated: June 30, 2010
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
Coronary artery disease
Coronary artery bypass graft surgery
SPECT
Adenosin

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014