Clinical trial NCT00005197: Predictors of Perioperative Cardiac Morbidity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Myocardial Infarction
Ventricular Arrhythmia
Coronary Disease
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To determine the predictors of perioperative cardiac morbidity and mortality in patients at high risk who underwent major noncardiac surgery with general anesthesia.

Detailed description: BACKGROUND:

Of the 25 million patients who undergo noncardiac surgery in the United States each year, approximately three million have or are at risk of having coronary artery disease. Despite advances in the diagnosis and therapy of coronary artery disease, approximately 50,000 of these patients have a perioperative myocardial infarction, and more than half of the 40,000 deaths after surgery are caused by cardiac events. For perioperative myocardial infarction alone, health care costs exceeded $500 million per year in the 1980s. Determining the risk factors for adverse postoperative cardiac outcomes allowed the development of preventive strategies and the efficient allocation of health care resources.

DESIGN NARRATIVE:

Historical, clinical, laboratory, and physiologic data on the subjects were collected during hospitalization for major elective noncardiac surgery with general anesthesia and for six to 24 months after surgery. Myocardial ischemia was assessed by continuous electrocardiographic monitoring, beginning two days before surgery and continuing for two days after. The study published many findings under the title Study of Perioperative Ischemia.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Mangano DT, Browner WS, Hollenberg M, London MJ, Tubau JF, Tateo IM. Association of perioperative myocardial ischemia with cardiac morbidity and mortality in men undergoing noncardiac surgery. The Study of Perioperative Ischemia Research Group. N Engl J Med. 1990 Dec 27;323(26):1781-8. doi: 10.1056/NEJM199012273232601.
citation: Mangano DT, Hollenberg M, Fegert G, Meyer ML, London MJ, Tubau JF, Krupski WC. Perioperative myocardial ischemia in patients undergoing noncardiac surgery--I: Incidence and severity during the 4 day perioperative period. The Study of Perioperative Ischemia (SPI) Research Group. J Am Coll Cardiol. 1991 Mar 15;17(4):843-50. doi: 10.1016/0735-1097(91)90863-5.
citation: Mangano DT, Wong MG, London MJ, Tubau JF, Rapp JA. Perioperative myocardial ischemia in patients undergoing noncardiac surgery--II: Incidence and severity during the 1st week after surgery. The Study of Perioperative Ischemia (SPI) Research Group. J Am Coll Cardiol. 1991 Mar 15;17(4):851-7. doi: 10.1016/0735-1097(91)90864-6.
citation: Smith RC, Leung JM, Keith FM, Merrick S, Mangano DT. Ventricular dysrhythmias in patients undergoing coronary artery bypass graft surgery: incidence, characteristics, and prognostic importance. Study of Perioperative Ischemia (SPI) Research Group. Am Heart J. 1992 Jan;123(1):73-81. doi: 10.1016/0002-8703(92)90749-l.
citation: Mangano DT, Siliciano D, Hollenberg M, Leung JM, Browner WS, Goehner P, Merrick S, Verrier E. Postoperative myocardial ischemia. Therapeutic trials using intensive analgesia following surgery. The Study of Perioperative Ischemia (SPI) Research Group. Anesthesiology. 1992 Mar;76(3):342-53.
citation: Browner WS, Li J, Mangano DT. In-hospital and long-term mortality in male veterans following noncardiac surgery. The Study of Perioperative Ischemia Research Group. JAMA. 1992 Jul 8;268(2):228-32.
citation: O'Kelly B, Browner WS, Massie B, Tubau J, Ngo L, Mangano DT. Ventricular arrhythmias in patients undergoing noncardiac surgery. The Study of Perioperative Ischemia Research Group. JAMA. 1992 Jul 8;268(2):217-21. doi: 10.1001/jama.268.2.217.
citation: Krupski WC, Layug EL, Reilly LM, Rapp JH, Mangano DT. Comparison of cardiac morbidity between aortic and infrainguinal operations. Study of Perioperative Ischemia (SPI) Research Group. J Vasc Surg. 1992 Feb;15(2):354-63; discussion 364-5.
citation: Mangano DT, London MJ, Tubau JF, Browner WS, Hollenberg M, Krupski W, Layug EL, Massie B. Dipyridamole thallium-201 scintigraphy as a preoperative screening test. A reexamination of its predictive potential. Study of Perioperative Ischemia Research Group. Circulation. 1991 Aug;84(2):493-502. doi: 10.1161/01.cir.84.2.493.
citation: Mangano DT. Myocardial ischemia following surgery: preliminary findings. Study of Perioperative Ischemia (SPI) Research Group. J Card Surg. 1990 Sep;5(3 Suppl):288-93. doi: 10.1111/jocs.1990.5.3s.288.
citation: Mangano DT. Dynamic predictors of perioperative risk. Study of Perioperative Ischemia (SPI) Research Group. J Card Surg. 1990 Sep;5(3 Suppl):231-6. doi: 10.1111/jocs.1990.5.3s.231.
citation: Leung JM, Hollenberg M, O'Kelly BF, Kao A, Mangano DT. Effects of steal-prone anatomy on intraoperative myocardial ischemia. The SPI Research Group. J Am Coll Cardiol. 1992 Nov 1;20(5):1205-12. doi: 10.1016/0735-1097(92)90379-2.
citation: Hollenberg M, Mangano DT, Browner WS, London MJ, Tubau JF, Tateo IM. Predictors of postoperative myocardial ischemia in patients undergoing noncardiac surgery. The Study of Perioperative Ischemia Research Group. JAMA. 1992 Jul 8;268(2):205-9.
citation: Simon JA, Browner WS, Mangano DT. Predictors of smoking relapse after noncardiac surgery. Study of Perioperative Ischemia (SPI) Research Group. Am J Public Health. 1992 Sep;82(9):1235-7. doi: 10.2105/ajph.82.9.1235.
citation: Mangano DT, Browner WS, Hollenberg M, Li J, Tateo IM. Long-term cardiac prognosis following noncardiac surgery. The Study of Perioperative Ischemia Research Group. JAMA. 1992 Jul 8;268(2):233-9. doi: 10.1001/jama.268.2.233.
citation: Eisenberg MJ, London MJ, Leung JM, Browner WS, Hollenberg M, Tubau JF, Tateo IM, Schiller NB, Mangano DT. Monitoring for myocardial ischemia during noncardiac surgery. A technology assessment of transesophageal echocardiography and 12-lead electrocardiography. The Study of Perioperative Ischemia Research Group. JAMA. 1992 Jul 8;268(2):210-6. doi: 10.1001/jama.268.2.210.
citation: Leung JM, Goehner P, O'Kelly BF, Hollenberg M, Pineda N, Cason BA, Mangano DT. Isoflurane anesthesia and myocardial ischemia: comparative risk versus sufentanil anesthesia in patients undergoing coronary artery bypass graft surgery. The SPI (Study of Perioperative Ischemia) Research Group. Anesthesiology. 1991 May;74(5):838-47.
citation: Smith RC, Leung JM, Mangano DT. Postoperative myocardial ischemia in patients undergoing coronary artery bypass graft surgery. S.P.I. Research Group. Anesthesiology. 1991 Mar;74(3):464-73. doi: 10.1097/00000542-199103000-00013.
citation: Leung JM, O'Kelly BF, Mangano DT. Relationship of regional wall motion abnormalities to hemodynamic indices of myocardial oxygen supply and demand in patients undergoing CABG surgery. Anesthesiology. 1990 Nov;73(5):802-14. doi: 10.1097/00000542-199011000-00002.
citation: London MJ, Tubau JF, Wong MG, Layug E, Hollenberg M, Krupski WC, Rapp JH, Browner WS, Mangano DT. The "natural history" of segmental wall motion abnormalities in patients undergoing noncardiac surgery. S.P.I. Research Group. Anesthesiology. 1990 Oct;73(4):644-55. doi: 10.1097/00000542-199010000-00010.
citation: Mangano DT. Perioperative cardiac morbidity. Anesthesiology. 1990 Jan;72(1):153-84. doi: 10.1097/00000542-199001000-00025. No abstract available.
citation: Krupski WC, Layug EL, Reilly LM, Rapp JH, Mangano DT. Comparison of cardiac morbidity rates between aortic and infrainguinal operations: two-year follow-up. Study of Perioperative Ischemia Research Group. J Vasc Surg. 1993 Oct;18(4):609-15; discussion 615-7.
citation: Knight AA, Hollenberg M, London MJ, Mangano DT. Myocardial ischemia in patients awaiting coronary artery bypass grafting. Am Heart J. 1989 Jun;117(6):1189-95. doi: 10.1016/0002-8703(89)90395-5.
citation: Knight AA, Hollenberg M, London MJ, Tubau J, Verrier E, Browner W, Mangano DT. Perioperative myocardial ischemia: importance of the preoperative ischemic pattern. Anesthesiology. 1988 May;68(5):681-8.
citation: O'Kelly BF, Tubau JF, Knight AA, London MJ, Verrier ED, Mangano DT. Measurement of left ventricular contractility using transesophageal echocardiography in patients undergoing coronary artery bypass grafting. The Study of Perioperative Ischemia (SPI) Research Group. Am Heart J. 1991 Oct;122(4 Pt 1):1041-9. doi: 10.1016/0002-8703(91)90470-3.
citation: Leung JM. The role of hemodynamics in perioperative myocardial ischemia. Int Anesthesiol Clin. 1992 Winter;30(1):63-79. doi: 10.1097/00004311-199200000-00005. No abstract available.
citation: Massie BM, Mangano DT. Assessment of perioperative risk: have we put the cart before the horse. J Am Coll Cardiol. 1993 May;21(6):1353-6. doi: 10.1016/0735-1097(93)90308-n. No abstract available.
citation: Hollenberg M, Mangano DT. Therapeutic approaches to postoperative ischemia. The Study of Perioperative Ischemia Research Group. Am J Cardiol. 1994 Mar 10;73(6):30B-33B. doi: 10.1016/0002-9149(94)90263-1.
citation: Mangano DT, Layug EL, Wallace A, Tateo I. Effect of atenolol on mortality and cardiovascular morbidity after noncardiac surgery. Multicenter Study of Perioperative Ischemia Research Group. N Engl J Med. 1996 Dec 5;335(23):1713-20. doi: 10.1056/NEJM199612053352301.
citation: Halm EA, Browner WS, Tubau JF, Tateo IM, Mangano DT. Echocardiography for assessing cardiac risk in patients having noncardiac surgery. Study of Perioperative Ischemia Research Group. Ann Intern Med. 1996 Sep 15;125(6):433-41. doi: 10.7326/0003-4819-125-6-199609150-00001.