NCT00294814

Brief Summary

The purpose of this study is to test the hypothesis that using three different techniques to anastomose coronary grafts to the aorta: partial occlusion, single cross clamp, or using the Heartstring anastomotic device, will change the amount of gas and solid microemboli as detected by the EmbodopR transcranial Doppler (TCD) system and consequently the neurocognitive performance of patients after coronary bypass operation.

Trial Health

55
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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
Last Updated

March 20, 2007

Status Verified

May 1, 2006

First QC Date

February 20, 2006

Last Update Submit

March 19, 2007

Conditions

Intracranial Embolism and ThrombosisPostoperative Complications

Keywords

Cardiac SurgeryCABGMicroemboliTranscranial DopplerCognitive DeclineAnastomotic DeviceProximal AnastomosisCoronary Artery Bypass Graft (CABG)

Outcome Measures

Primary Outcomes (2)

  • Number of gas\solid microemboli detected by TCD

  • Neurocognitive performance

Secondary Outcomes (3)

  • Mortality

  • Organ failure (including brain damage)

  • Intensive care unit (ICU) length of stay\hospitalization

Interventions

Proximal anastomosis using Heartstring anastomotic deviceDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients hospitalized for surgical coronary revascularization at the Department of Cardiac Surgery of Rambam Medical Center, Haifa, Israel.
  • Patients should be conscious and cooperative to perform neurocognitive evaluation.

You may not qualify if:

  • Patients that lack "temporal window" for TCD monitoring will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Zvi Adler

Haifa, 31096, Israel

RECRUITING

MeSH Terms

Conditions

Intracranial Embolism and ThrombosisPostoperative ComplicationsCognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesThromboembolismEmbolism and ThrombosisPathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Zvi Adler, MD

    Rappaport Faculty of Medicine

    STUDY DIRECTOR

  • Simcha Milo, Prof.

    Rappaport Faculty of Medicine

    STUDY CHAIR

  • Majed Kabaha, MD

    Cardiac Surgery Dep. Rambam Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adler Zvi, MD

CONTACT

972-50-2061069z_adler@rambam.health.gov.il

Majed F Kabaha, MD

CONTACT

972-50-2064587m_kabha@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2006

First Posted

February 22, 2006

Last Updated

March 20, 2007

Record last verified: 2006-05

Locations

IL(1)