Cardiovascular DiseasesNCT00005690
Improving Outcomes and Quality of Life After CABG
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
Among patients undergoing elective primary coronary artery bypass graft (CABG), the principal objective of this randomized trial was to compare the efficacy of two strategies of intra-operative hemodynamic management during cardiopulmonary bypass in preventing peri-operative cardiac, cognitive and neurologic morbidity… 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, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1991to Nov 2000
- 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
Among patients undergoing elective primary coronary artery bypass graft (CABG), the principal objective of this randomized trial was to compare the efficacy of two strategies of intra-operative hemodynamic management during cardiopulmonary bypass in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality, and post-operative deterioration in patients' quality of life as measured by the SF-36.
Read the detailed description
BACKGROUND:
Surgical myocardial revascularization (CABG) is an effective treatment for triple vessel and left main coronary artery disease used for thousands of patients annually in the United States. CABG certainly prolongs life, and data demonstrates that it improves functional status for the majority of patients. The intervention in this trial is based upon the outcomes of the investigators' first trial, which showed a benefit to maintaining mean intra-bypass mean arterial pressure (MAP) at 65 mm Hg in the high MAP group vs. 52 mm Hg in the low MAP group. Intra-bypass MAPs corrected for intervals less than full flow were 81 mm Hg for the high group and 59 mm Hg for the low MAP group. Cardiac and neurologic morbidity and mortality were 4.8 percent in the high MAP group versus 12.9 percent in the low MAP group (p=.026). All adverse outcomes were lower in the high MAP group (16.1 percent) than in the low MAP group (27.4 percent). Data from the previous study also suggests that outcomes may be further improved by maintaining intra-bypass MAP close to the patient's preoperative MAP. This is consistent with the investigators previous work in non-cardiac surgery, which shows that maintaining MAP within patient's usual autoregulatory range is associated with lower cardiac and renal complication rates. This study will determine whether refining the approach to hemodynamic management will further improve patient outcomes after coronary revascularization.
DESIGN NARRATIVE:
The First Clinical Study
During the first three years of grant support, from August, 1991 to November, 1995, clinical research was conducted on a comparison of intraoperative high versus low mean arterial pressure (MAP) on outcomes after coronary artery bypass. In this study, 248 patients undergoing primary, nonemergency coronary bypass were randomized to either low (n = 124) or high (n = 124) mean arterial pressure during cardiopulmonary bypass. The impact of the mean arterial pressure strategies on the following outcomes was assessed: mortality, cardiac morbidity, neurologic morbidity, cognitive deterioration, and changes in quality of life. All patients were observed prospectively to six months after the operation. Results are described under the Results Section.
Second Clinical Study
The second clinical study under grant R01HL44719, began in December, 1995 and was a prospective trial of 412 patients who were evaluated pre-operatively, monitored intra-operatively and followed post-operatively according to a standardized surveillance protocol. Patients were randomized to two forms of hemodynamic management during cardiopulmonary bypass. In one group, the intra-operative mean arterial pressure (MAP) during bypass was maintained at 65 mm Hg (or 81 mm Hg at full flow), thus employing the most effective strategy from the investigators' first trial. In the second group, the intra-operative MAP was maintained at their pre-operative MAP (but below 90 mm Hg), a strategy supported by data from the first trial. The principal outcome was the occurrence of any one of the following: mortality at six months, major cardiopulmonary morbidity (i.e., myocardial infarction, pulmonary edema, cardiogenic shock or low flow state), cognitive complications (defined by a summary definition which included improvement and decline on neuropsychologic tests of memory, psychomotor/attention, and linguistic function), major neurologic complications (i.e., new focal deficits, such as hemiplegia, aphasia, cortical blindness) and significant deterioration in functional status at six months postoperatively. The long term objective was to preserve and further improve the quality of life after CABG.
Although the study was described as a clinical trial, the Behavioral Medicine Study Section defined it as clinical research, not a NIH-defined Phase III trial.
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, Coronary Disease
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, 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 startAug 1991
- Study completionNov 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Time perspective
- Prospective
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Mary Charlson, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005690
- Sponsor's protocol ID
- 4194
- Other IDs
- R01HL044719
- Status last verified
- Jan 2005
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Gold JP, Charlson ME, Williams-Russo P, Szatrowski TP, Peterson JC, Pirraglia PA, Hartman GS, Yao FS, Hollenberg JP, Barbut D, et al. Improvement of outcomes after coronary artery bypass. A randomized trial comparing intraoperative high versus low mean arterial pressure. J Thorac Cardiovasc Surg. 1995 Nov;110(5):1302-11; discussion 1311-4. doi: 10.1016/S0022-5223(95)70053-6.
PubMed 7475182Hartman GS, Peterson J, Konstadt SN, Hahn R, Szatrowski TP, Charlson ME, Bruefach M 3rd. High reproducibility in the interpretation of intraoperative transesophageal echocardiographic evaluation of aortic atheromatous disease. Anesth Analg. 1996 Mar;82(3):539-43. doi: 10.1097/00000539-199603000-00020.
PubMed 8623958Hollenberg JP, Pirraglia PA, Williams-Russo P, Hartman GS, Gold JP, Yao FS, Thomas SJ. Computerized data collection in the operating room during coronary artery bypass surgery: a comparison to the hand-written anesthesia record. J Cardiothorac Vasc Anesth. 1997 Aug;11(5):545-51. doi: 10.1016/s1053-0770(97)90001-x.
PubMed 9263082Hartman GS, Yao FS, Bruefach M 3rd, Barbut D, Peterson JC, Purcell MH, Charlson ME, Gold JP, Thomas SJ, Szatrowski TP. Severity of aortic atheromatous disease diagnosed by transesophageal echocardiography predicts stroke and other outcomes associated with coronary artery surgery: a prospective study. Anesth Analg. 1996 Oct;83(4):701-8. doi: 10.1097/00000539-199610000-00007.
PubMed 8831306Charlson M, Krieger KH, Peterson JC, Hayes J, Isom OW. Predictors and outcomes of cardiac complications following elective coronary bypass grafting. Proc Assoc Am Physicians. 1999 Nov-Dec;111(6):622-32. doi: 10.1046/j.1525-1381.1999.99130.x.
PubMed 10591092Pirraglia PA, Peterson JC, Williams-Russo P, Gorkin L, Charlson ME. Depressive symptomatology in coronary artery bypass graft surgery patients. Int J Geriatr Psychiatry. 1999 Aug;14(8):668-80. doi: 10.1002/(sici)1099-1166(199908)14:83.0.co;2-9.
PubMed 10489658Pirraglia PA, Peterson JC, Hartman GS, Yao FS, Thomas SJ, Charlson ME. The efficacy and safety of a pharmacologic protocol for maintaining coronary artery bypass patients at a higher mean arterial pressure during cardiopulmonary bypass. J Extra Corpor Technol. 1998 Jun;30(2):64-72.
PubMed 10182115Peterson JC, Charlson ME, Williams-Russo P, Krieger KH, Pirraglia PA, Meyers BS, Alexopoulos GS. New postoperative depressive symptoms and long-term cardiac outcomes after coronary artery bypass surgery. Am J Geriatr Psychiatry. 2002 Mar-Apr;10(2):192-8.
PubMed 11925280
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes and Quality of Life After CABG
- ClinicalTrials.gov ID
- NCT00005690
- Acronym / sponsor ID
- 4194
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1991
- Study completion
- Nov 2000 (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.
Among patients undergoing elective primary coronary artery bypass graft (CABG), the principal objective of this randomized trial was to compare the efficacy of two strategies of intra-operative hemodynamic management during cardiopulmonary bypass in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality, and post-operative deterioration in patients' quality of life as measured by the SF-36.
Detailed description
BACKGROUND:
Surgical myocardial revascularization (CABG) is an effective treatment for triple vessel and left main coronary artery disease used for thousands of patients annually in the United States. CABG certainly prolongs life, and data demonstrates that it improves functional status for the majority of patients. The intervention in this trial is based upon the outcomes of the investigators' first trial, which showed a benefit to maintaining mean intra-bypass mean arterial pressure (MAP) at 65 mm Hg in the high MAP group vs. 52 mm Hg in the low MAP group. Intra-bypass MAPs corrected for intervals less than full flow were 81 mm Hg for the high group and 59 mm Hg for the low MAP group. Cardiac and neurologic morbidity and mortality were 4.8 percent in the high MAP group versus 12.9 percent in the low MAP group (p=.026). All adverse outcomes were lower in the high MAP group (16.1 percent) than in the low MAP group (27.4 percent). Data from the previous study also suggests that outcomes may be further improved by maintaining intra-bypass MAP close to the patient's preoperative MAP. This is consistent with the investigators previous work in non-cardiac surgery, which shows that maintaining MAP within patient's usual autoregulatory range is associated with lower cardiac and renal complication rates. This study will determine whether refining the approach to hemodynamic management will further improve patient outcomes after coronary revascularization.
DESIGN NARRATIVE:
The First Clinical Study
During the first three years of grant support, from August, 1991 to November, 1995, clinical research was conducted on a comparison of intraoperative high versus low mean arterial pressure (MAP) on outcomes after coronary artery bypass. In this study, 248 patients undergoing primary, nonemergency coronary bypass were randomized to either low (n = 124) or high (n = 124) mean arterial pressure during cardiopulmonary bypass. The impact of the mean arterial pressure strategies on the following outcomes was assessed: mortality, cardiac morbidity, neurologic morbidity, cognitive deterioration, and changes in quality of life. All patients were observed prospectively to six months after the operation. Results are described under the Results Section.
Second Clinical Study
The second clinical study under grant R01HL44719, began in December, 1995 and was a prospective trial of 412 patients who were evaluated pre-operatively, monitored intra-operatively and followed post-operatively according to a standardized surveillance protocol. Patients were randomized to two forms of hemodynamic management during cardiopulmonary bypass. In one group, the intra-operative mean arterial pressure (MAP) during bypass was maintained at 65 mm Hg (or 81 mm Hg at full flow), thus employing the most effective strategy from the investigators' first trial. In the second group, the intra-operative MAP was maintained at their pre-operative MAP (but below 90 mm Hg), a strategy supported by data from the first trial. The principal outcome was the occurrence of any one of the following: mortality at six months, major cardiopulmonary morbidity (i.e., myocardial infarction, pulmonary edema, cardiogenic shock or low flow state), cognitive complications (defined by a summary definition which included improvement and decline on neuropsychologic tests of memory, psychomotor/attention, and linguistic function), major neurologic complications (i.e., new focal deficits, such as hemiplegia, aphasia, cortical blindness) and significant deterioration in functional status at six months postoperatively. The long term objective was to preserve and further improve the quality of life after CABG.
Although the study was described as a clinical trial, the Behavioral Medicine Study Section defined it as clinical research, not a NIH-defined Phase III trial.
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
- Time perspective
- Prospective
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 13 May 2016.
- Background: PubMed 7475182Gold JP, Charlson ME, Williams-Russo P, Szatrowski TP, Peterson JC, Pirraglia PA, Hartman GS, Yao FS, Hollenberg JP, Barbut D, et al. Improvement of outcomes after coronary artery bypass. A randomized trial comparing intraoperative high versus low mean arterial pressure. J Thorac Cardiovasc Surg. 1995 Nov;110(5):1302-11; discussion 1311-4. doi: 10.1016/S0022-5223(95)70053-6.
- Background: PubMed 8623958Hartman GS, Peterson J, Konstadt SN, Hahn R, Szatrowski TP, Charlson ME, Bruefach M 3rd. High reproducibility in the interpretation of intraoperative transesophageal echocardiographic evaluation of aortic atheromatous disease. Anesth Analg. 1996 Mar;82(3):539-43. doi: 10.1097/00000539-199603000-00020.
- Background: PubMed 9263082Hollenberg JP, Pirraglia PA, Williams-Russo P, Hartman GS, Gold JP, Yao FS, Thomas SJ. Computerized data collection in the operating room during coronary artery bypass surgery: a comparison to the hand-written anesthesia record. J Cardiothorac Vasc Anesth. 1997 Aug;11(5):545-51. doi: 10.1016/s1053-0770(97)90001-x.
- Background: PubMed 8831306Hartman GS, Yao FS, Bruefach M 3rd, Barbut D, Peterson JC, Purcell MH, Charlson ME, Gold JP, Thomas SJ, Szatrowski TP. Severity of aortic atheromatous disease diagnosed by transesophageal echocardiography predicts stroke and other outcomes associated with coronary artery surgery: a prospective study. Anesth Analg. 1996 Oct;83(4):701-8. doi: 10.1097/00000539-199610000-00007.
- Background: PubMed 10591092Charlson M, Krieger KH, Peterson JC, Hayes J, Isom OW. Predictors and outcomes of cardiac complications following elective coronary bypass grafting. Proc Assoc Am Physicians. 1999 Nov-Dec;111(6):622-32. doi: 10.1046/j.1525-1381.1999.99130.x.
- Background: PubMed 10489658Pirraglia PA, Peterson JC, Williams-Russo P, Gorkin L, Charlson ME. Depressive symptomatology in coronary artery bypass graft surgery patients. Int J Geriatr Psychiatry. 1999 Aug;14(8):668-80. doi: 10.1002/(sici)1099-1166(199908)14:83.0.co;2-9.
- Background: PubMed 10182115Pirraglia PA, Peterson JC, Hartman GS, Yao FS, Thomas SJ, Charlson ME. The efficacy and safety of a pharmacologic protocol for maintaining coronary artery bypass patients at a higher mean arterial pressure during cardiopulmonary bypass. J Extra Corpor Technol. 1998 Jun;30(2):64-72.
- Background: PubMed 11925280Peterson JC, Charlson ME, Williams-Russo P, Krieger KH, Pirraglia PA, Meyers BS, Alexopoulos GS. New postoperative depressive symptoms and long-term cardiac outcomes after coronary artery bypass surgery. Am J Geriatr Psychiatry. 2002 Mar-Apr;10(2):192-8.
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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.
Mary Charlson
Weill Medical College of Cornell University
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 13 May 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 NCT00005690, which also lists 8 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 13 May 2016; AzTrials last refreshed its copy on 7 Nov 2026.