Surgical Manipulation of the Aorta and Cerebral Infarction

NCT00558779 | Unknown Phase 2 DMC

• 2 other identifiers: 49/07F/13/03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Coronary Heart Disease; Stroke; Cerebral Infarction

Keywords

Coronary artery bypass; off pump coronary artery bypass grafting (OPCAB)

Outcome Measures

Primary Outcomes (1)

• occurrence and number of cerebral infarctions assessed by magnetic resonance imaging

  2-7 days after surgery

Secondary Outcomes (7)

• mortality

  within hospital stay following surgery

• stroke

  within hospital stay following surgery

• delirium

  within hospital stay following surgery

• neurocognitive performance

  within hospital stay following surgery

• multi-organ failure

  within hospital stay following surgery

Study Arms (2)

1

EXPERIMENTAL

Procedure: OBCAB (Off Pump Coronary Artery Bypass Grafting)

2

ACTIVE COMPARATOR

Procedure: CABG (coronary artery bypass grafting)

Interventions

OBCAB (Off Pump Coronary Artery Bypass Grafting) PROCEDURE

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)

1

CABG (coronary artery bypass grafting) PROCEDURE

conventional CABG with cardiopulmonary bypass

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wuerzburg: lead
• Deutsche Stiftung für Herzforschung: collaborator

Study Sites (1)

Department of Cardiothoracic Surgery, University Hospital Wuerzburg

Würzburg, 97080, Germany

RECRUITING

Related Publications (5)

• 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.

  PMID: 11441193 BACKGROUND

• 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.

  PMID: 8948560 BACKGROUND

• 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.

  PMID: 12022522 BACKGROUND

• 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.

  PMID: 15927994 BACKGROUND

• 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.

  PMID: 12117356 BACKGROUND

MeSH Terms

Conditions

Coronary Disease; Stroke; Cerebral Infarction

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Wilko Reents, MD

  Department of Cardiothoracic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wilko Reents, MD

CONTACT

0049 - 931 - 201 - 33001; reents_w@klinik.uni-wuerzburg.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 15, 2007
• Study Start: November 1, 2007
• Study Completion: May 1, 2010
• Last Updated: November 22, 2007

Record last verified: 2007-11

Locations

DE (1)