NCT00286559

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2006

Typical duration for phase_1 coronary-artery-disease

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

First QC Date

February 2, 2006

Last Update Submit

March 24, 2015

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseaseCoronary artery bypass graft surgerySPECTAdenosin

Outcome Measures

Primary Outcomes (1)

  • coronary bypass graft patency

    30 days

Secondary Outcomes (1)

  • long-term survival

    12 months

Interventions

SonoVueDRUG
OptisonDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

contrast agent BR1FS 069

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Manfred D Seeberger, Prof. Dr.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2006

First Posted

February 3, 2006

Study Start

August 1, 2006

Study Completion

December 1, 2008

Last Updated

March 25, 2015

Record last verified: 2015-03