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TCD Detection of Gas and Solid Micro-Emboli in Patients Undergoing Coronary Artery Bypass Grafting (CABG): The Influence of Proximal Anastomosis Technique

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00294814
First received: February 20, 2006
Last updated: March 19, 2007
Last verified: May 2006
  Purpose

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.


Condition Intervention
Intracranial Embolism and Thrombosis
Postoperative Complications
Device: Proximal anastomosis using Heartstring anastomotic device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Gas and Solid Brain Microembolization Detected by the EmbodopR TCD System During Proximal Coronary Graft Anastomosis Done With Aortic Cross Clamping, Partial Occlusion or the HeartstringR Device and Their Effect on Neurocognitive Performance After Coronary Bypass Operation

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Number of gas\solid microemboli detected by TCD
  • Neurocognitive performance

Secondary Outcome Measures:
  • Mortality
  • Organ failure (including brain damage)
  • Intensive care unit (ICU) length of stay\hospitalization

Estimated Enrollment: 100
Detailed Description:

It is not uncommon for a cardiac surgical patient to have his heart fixed but his brain damaged. Sometimes the damage is overt and manifests itself as a major neurological deficiency. The frequency of stroke, the so called type 1 damage, is reported to be between 1 and 4 percent. This may increase mortality from 1.4% to 22% and hospitalization from 6.6 days to 17.5 days. Diffuse encephalopathy, presenting as delirium, confusion, coma and seizures, so called type 2 damage, is reported to appear in a much higher frequency of 3% to 7%, depending on timing and methods of evaluation. This type of damage will increase mortality from 1.4% to 7.5% and hospitalization from 6.6% to 15.2%. Sometimes it is more subtle and appears as neurocognitive decline. This type of damage may be found in 53% of the patients at discharge, in 24% after six months and the frequency rises again to 42% at five years. The impact on the patient and his family might be devastating and the burden on the medical system and society enormous. Long term, moderate to severe disability may affect 69% of the stroke patients and survival may decline to 67% after one year.

After years of research efforts it became evident that inadequate global blood flow to the brain is relatively uncommon and cerebral hemorrhage is a rare cause of brain damage during cardiac operations. It also became evident that one of the most important damage mechanisms is embolization to the brain and the inflammatory response which amplifies the ischemic embolic damage. Looking for possible embolic sources by monitoring embolic signals (HITS) on the transcranial doppler (TCD) tracings, researchers found that manipulation of the aorta during cardiac surgery, like cannulation and especially clamping is a major source of emboli. Using the side biting clamp while performing proximal anastomosis has the potential to crush the aortic wall and release macro and micro emboli especially when the aorta is atherosclerotic. Using a single cross clamp technique might eliminate the aortic wall solid debris but introduce air emboli instead.

Dealing with the same problem, a few proximal anastomotic devices have been introduced and most of them withdrawn from the market because of inferior patency rate. The Heartstring proximal anastomotic device is one of the recently introduced devices for which early good patency rate has been demonstrated. The advantages, in terms of less brain embolization or improved neurologic outcome, have never been demonstrated for the Heartstring or any other anastomotic device.

A recent potential breakthrough in this field of emboli research and prevention in order to improve neurologic outcome after cardiac surgery is the introduction of the EmbodopR system by DWL. This is a high quality TCD system which has been further developed to monitor cerebral emboli. It contains a module which automatically screens every event suspected as embolic, eliminates those recognized as artifacts according to four different criteria and records only real embolic events. Another module can differentiate every event as gas or solid emboli by simultaneously insonating the middle cerebral artery blood with tow ultrasound beams, each of different frequency. The result is a new ability for real time monitoring and characterization of embolic events during cardiac operations.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients that lack "temporal window" for TCD monitoring will be excluded.
  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: NCT00294814

Contacts
Contact: Adler Zvi, MD 972-50-2061069 z_adler@rambam.health.gov.il
Contact: Majed F Kabaha, MD 972-50-2064587 m_kabha@rambam.health.gov.il

Locations
Israel
Dr Zvi Adler Recruiting
Haifa., Israel, 31096
Contact: Zvi Adler, MD    972-50-2061069    z_adler@rambam.health.gov.il   
Contact: Majed Kabaha, MD    972-50-2064587    m_kabha@rambam.health.gov.il   
Principal Investigator: Majed Kabaha, MD         
Sub-Investigator: Sammer Diab, MD, PhD         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Study Director: Zvi Adler, MD Rappaport Faculty of Medicine
Study Chair: Simcha Milo, Prof. Rappaport Faculty of Medicine
Principal Investigator: Majed Kabaha, MD Cardiac Surgery Dep. Rambam Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00294814     History of Changes
Other Study ID Numbers: EMBO_CTIL
Study First Received: February 20, 2006
Last Updated: March 19, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
Cardiac Surgery
CABG
Microemboli
Transcranial Doppler
Cognitive Decline
Anastomotic Device
Proximal Anastomosis
Coronary Artery Bypass Graft (CABG)

Additional relevant MeSH terms:
Embolism and Thrombosis
Intracranial Embolism and Thrombosis
Intracranial Embolism
Postoperative Complications
Thrombosis
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Thromboembolism
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014