search
Back to results

Predictors of Perioperative Cardiac Morbidity

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    March 15, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
    search

    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
    background
    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
    background
    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
    background
    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
    background
    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
    background
    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
    background
    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
    background
    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
    background
    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
    background
    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
    background
    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
    background
    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
    background
    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
    background
    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
    background
    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
    background

    Learn more about this trial

    Predictors of Perioperative Cardiac Morbidity

    We'll reach out to this number within 24 hrs