Predictors of Perioperative Cardiac Morbidity
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005197
First Posted
May 25, 2000
Last Updated
March 15, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005197
Brief Title
Predictors of Perioperative Cardiac Morbidity
Study Type
Observational
2. Study Status
Record Verification Date
May 2000
Overall Recruitment Status
Completed
Study Start Date
December 1986 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 1991 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Myocardial Infarction, Ventricular Arrhythmia, Coronary Disease
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
2247116
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.
Results Reference
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PubMed Identifier
1999618
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.
Results Reference
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PubMed Identifier
1999619
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.
Results Reference
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PubMed Identifier
1370363
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.
Results Reference
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PubMed Identifier
1531742
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.
Results Reference
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PubMed Identifier
1608142
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.
Results Reference
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PubMed Identifier
1608140
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.
Results Reference
background
PubMed Identifier
1735896
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.
Results Reference
background
PubMed Identifier
1860194
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.
Results Reference
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PubMed Identifier
2133859
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.
Results Reference
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PubMed Identifier
2133848
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.
Results Reference
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PubMed Identifier
1401623
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.
Results Reference
background
PubMed Identifier
1535109
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.
Results Reference
background
PubMed Identifier
1503164
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.
Results Reference
background
PubMed Identifier
1608143
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.
Results Reference
background
PubMed Identifier
1608139
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.
Results Reference
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PubMed Identifier
1826989
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.
Results Reference
background
PubMed Identifier
2001026
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.
Results Reference
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PubMed Identifier
2240670
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.
Results Reference
background
PubMed Identifier
2221433
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.
Results Reference
background
PubMed Identifier
2404426
Citation
Mangano DT. Perioperative cardiac morbidity. Anesthesiology. 1990 Jan;72(1):153-84. doi: 10.1097/00000542-199001000-00025. No abstract available.
Results Reference
background
PubMed Identifier
8411468
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.
Results Reference
background
PubMed Identifier
2786326
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.
Results Reference
background
PubMed Identifier
3259409
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.
Results Reference
background
PubMed Identifier
1927855
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.
Results Reference
background
PubMed Identifier
1577543
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.
Results Reference
background
PubMed Identifier
8473641
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.
Results Reference
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PubMed Identifier
8141077
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.
Results Reference
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PubMed Identifier
8929262
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. Erratum In: N Engl J Med 1997 Apr 3;336(14):1039.
Results Reference
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PubMed Identifier
8779454
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. Erratum In: Ann Intern Med 1997 Mar 15;126(6):494.
Results Reference
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Predictors of Perioperative Cardiac Morbidity
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