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Coronary Heart DiseasePhase 2NCT00558779

Surgical Manipulation of the Aorta and Cerebral Infarction

A Phase 2 study testing OBCAB (Off Pump Coronary Artery Bypass Grafting) and CABG (coronary artery bypass grafting) in people with Coronary Heart Disease and Stroke, run by University of Wuerzburg at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of the study is to compare two surgical strategies for coronary artery bypass grafting with respect to the occurrence of cerebral infarctions made visible by magnetic resonance imaging Read more about this study

Who is it for?
Any age
What is being tested?
OBCAB (Off Pump Coronary Artery Bypass Grafting) and CABG (coronary artery bypass grafting)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteGermany
Study dates
Nov 2007to May 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • age > 72
  • history of stroke
  • cerebrovascular artery disease with stenosis > 50%
  • peripheral arterial disease.

Who cannot join

  • urgent or emergency operation
  • unstable angina
  • reoperation
  • concomitant valvular disease requiring surgery
  • implanted pacemaker or other incorporated ferromagnetic material
  • claustrophobia.

Trial locations and contacts

1 site in 1 country.

Wilko Reents, MD contact

0049 - 931 - 201 - 33001

reents_w@klinik.uni-wuerzburg.de

Germany1 site, 1 recruiting

  • Department of Cardiothoracic Surgery, University Hospital Wuerzburg

    Würzburg, 97080

    Wilko Reents, MD, 0049-931-201-33001, reents_w@klinik.uni-wuerzburg.de

    Wilko Reents, MD

    Recruiting

Other trials in Germany

About this study

Official title: Surgical Manipulation of the Ascending Aorta and Cerebral Infarction Following CABG

The purpose of the study is to compare two surgical strategies for coronary artery bypass grafting with respect to the occurrence of cerebral infarctions made visible by magnetic resonance imaging

Read the detailed description

Stroke is one of the most devastating complications following coronary artery bypass grafting (CABG) with an overall incidence ranging from 2.0 % to 3.2 %. The presumed etiology for the majority of strokes after CABG is atheroembolism from the diseased aorta ascendens caused by surgical manipulation. Off-pump coronary artery bypass grafting (OPCAB) allows the construction of bypass grafts without surgical manipulation of the aorta. Yet a trial comparing different surgical strategies with stroke as the primary end point would require several thousand patients to achieve an adequate statistical power. The number of patients can be substantially reduced, if cerebral damage is assessed by diffusion-weighted magnetic resonance imaging (DW-MRI). Using DW-MRI we have recently demonstrated that 25% of a patient population undergoing CABG without an increased risk of stroke showed new cerebral infarctions. These new cerebral lesions all showed an embolic pattern, became visible at T2-weighted images and were clinically silent, e .g. did not cause a new focal neurologic deficit. Given the much higher frequency of cerebral lesions assessed by DW-MRI than clinically apparent stroke, DW-MRI is an ideal surrogate parameter for the assessment of cerebral damage in patients undergoing CABG.

The aim of the study is therefore, to investigate the influence of the surgical technique on the occurence of new ischemic cerebral lesions as assessed by DW-MRI in patients undergoing CABG in a prospective randomized setting. We hypothesize that OPCAB, which enables sparing of aortic manipulation, will reduce cerebral infarctions in patients with an increased risk for perioperative stroke.

Being tested
OBCAB (Off Pump Coronary Artery Bypass Grafting), CABG (coronary artery bypass grafting)
Keywords
Coronary artery bypass, off pump coronary artery bypass grafting (OPCAB)
Medical subject headings
Coronary Disease, Stroke, Cerebral Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OBCAB (Off Pump Coronary Artery Bypass Grafting)Procedure or surgery

    OPCAB with sparing of aortic manipulation (eg, no aortic cannulation for cardiopulmonary bypass, no aortic cross-clamp, no side-clamping of the aorta). Graft anastomosis to the central circulation with y-grafts on the arteria thoracica interna or on the aorta with help of the Heart-string-system (Guidant)

  • CABG (coronary artery bypass grafting)Procedure or surgery

    conventional CABG with cardiopulmonary bypass

Study groups in NCT00558779
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Procedure: OBCAB (Off Pump Coronary Artery Bypass Grafting)
2Active comparatorNot described
Receives: Procedure: CABG (coronary artery bypass grafting)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. occurrence and number of cerebral infarctions assessed by magnetic resonance imaging

    Measured: 2-7 days after surgery

Secondary outcomes (7)

  1. mortality

    Measured: within hospital stay following surgery

  2. stroke

    Measured: within hospital stay following surgery

  3. delirium

    Measured: within hospital stay following surgery

  4. neurocognitive performance

    Measured: within hospital stay following surgery

  5. multi-organ failure

    Measured: within hospital stay following surgery

  6. myocardial infarction

    Measured: within hospital stay following surgery

  7. completeness of revascularisation

    Measured: within hospital stay following surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2007 (estimated)
  2. Study startNov 2007
  3. Study completionMay 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00558779
Sponsor's protocol ID
49/07
Other IDs
F/13/03
Status last verified
Nov 2007
First submitted
14 Nov 2007
Last updated
22 Nov 2007
Results posted
No
Data monitoring committee
Yes

Publications

  • Stamou SC, Hill PC, Dangas G, Pfister AJ, Boyce SW, Dullum MK, Bafi AS, Corso PJ. Stroke after coronary artery bypass: incidence, predictors, and clinical outcome. Stroke. 2001 Jul;32(7):1508-13. doi: 10.1161/01.str.32.7.1508.

    PubMed 11441193

  • Roach GW, Kanchuger M, Mangano CM, Newman M, Nussmeier N, Wolman R, Aggarwal A, Marschall K, Graham SH, Ley C. Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators. N Engl J Med. 1996 Dec 19;335(25):1857-63. doi: 10.1056/NEJM199612193352501.

    PubMed 8948560

  • Calafiore AM, Di Mauro M, Teodori G, Di Giammarco G, Cirmeni S, Contini M, Iaco AL, Pano M. Impact of aortic manipulation on incidence of cerebrovascular accidents after surgical myocardial revascularization. Ann Thorac Surg. 2002 May;73(5):1387-93. doi: 10.1016/s0003-4975(02)03470-7.

    PubMed 12022522

  • Sellke FW, DiMaio JM, Caplan LR, Ferguson TB, Gardner TJ, Hiratzka LF, Isselbacher EM, Lytle BW, Mack MJ, Murkin JM, Robbins RC; American Heart Association. Comparing on-pump and off-pump coronary artery bypass grafting: numerous studies but few conclusions: a scientific statement from the American Heart Association council on cardiovascular surgery and anesthesia in collaboration with the interdisciplinary working group on quality of care and outcomes research. Circulation. 2005 May 31;111(21):2858-64. doi: 10.1161/CIRCULATIONAHA.105.165030.

    PubMed 15927994

  • Bendszus M, Reents W, Franke D, Mullges W, Babin-Ebell J, Koltzenburg M, Warmuth-Metz M, Solymosi L. Brain damage after coronary artery bypass grafting. Arch Neurol. 2002 Jul;59(7):1090-5. doi: 10.1001/archneur.59.7.1090.

    PubMed 12117356

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OBCAB (Off Pump Coronary Artery Bypass Grafting) and CABG (coronary artery bypass grafting) in people with Coronary Heart Disease and Stroke, run by University of Wuerzburg at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wilko Reents, MD (0049 - 931 - 201 - 33001, reents_w@klinik.uni-wuerzburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

occurrence and number of cerebral infarctions assessed by magnetic resonance imaging (time frame: 2-7 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00558779, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2007.

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