Cardiovascular DiseasesNCT00005197
Predictors of Perioperative Cardiac Morbidity
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the predictors of perioperative cardiac morbidity and mortality in patients at high risk who underwent major noncardiac surgery with general anesthesia. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 1986to Nov 1991
- Phase
- Observational
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine the predictors of perioperative cardiac morbidity and mortality in patients at high risk who underwent major noncardiac surgery with general anesthesia.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Myocardial Infarction, Ventricular Arrhythmia, Coronary Disease
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Myocardial Infarction, Coronary Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startDec 1986
- Study completionNov 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005197
- Sponsor's protocol ID
- 1076
- Other IDs
- R01HL036744
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
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.
PubMed 2247116Mangano 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.
PubMed 1999618Mangano 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.
PubMed 1999619Smith 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.
PubMed 1370363Mangano 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.
PubMed 1531742Browner 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.
PubMed 1608142O'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.
PubMed 1608140Krupski 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.
PubMed 1735896Mangano 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.
PubMed 1860194Mangano 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.
PubMed 2133859Mangano 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.
PubMed 2133848Leung 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.
PubMed 1401623Hollenberg 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.
PubMed 1535109Simon 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.
PubMed 1503164Mangano 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.
PubMed 1608143
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Perioperative Cardiac Morbidity
- ClinicalTrials.gov ID
- NCT00005197
- Acronym / sponsor ID
- 1076
- Conditions
- Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Myocardial Infarction, Ventricular Arrhythmia, Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Dec 1986
- Study completion
- Nov 1991 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Background: PubMed 2247116Mangano 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.
- Background: PubMed 1999618Mangano 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.
- Background: PubMed 1999619Mangano 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.
- Background: PubMed 1370363Smith 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.
- Background: PubMed 1531742Mangano 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.
- Background: PubMed 1608142Browner 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.
- Background: PubMed 1608140O'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.
- Background: PubMed 1735896Krupski 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.
- Background: PubMed 1860194Mangano 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.
- Background: PubMed 2133859Mangano 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.
- Background: PubMed 2133848Mangano 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.
- Background: PubMed 1401623Leung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005197, which also lists 30 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 16 Mar 2016.