Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032370
Status:
COMPLETED
Last Update Posted:
2015-06-26
First Post:
2002-03-19
Brief Title:
Does Prophylactic Coronary Artery Revascularization for High Risk Patients Reduce Long-term Risk of Mortality
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 411 - The Coronary Artery Revascularization Prophylaxis CARP Trial
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARP
Brief Summary:
Although a number of sophisticated diagnostic tests have been shown to be helpful in identifying patients at high risk for perioperative cardiac complications no study has addressed the most important question Should prophylactic coronary revascularization be performed prior to elective vascular surgery This study is designed to answer this question
Detailed Description:
Primary Hypothesis Prophylactic coronary artery revascularization in high risk patients scheduled for elective vascular surgery reduces long-term risk of mortality
Secondary Hypotheses Prophylactic coronary artery revascularization in high risk patients scheduled for elective vascular surgery reduces long-term risk of myocardial infarction and improves both cost-effectiveness of treatment and quality of life of the patients
Intervention 1 Medical therapy This is the current conservative practice Each local investigator will decide the best medical treatment consistent with that given to any patient scheduled for elective vascular surgery In patients with coronary artery disease long-term treatment would be expected to include a combination of antiplatelet agents beta-blockers calcium channel blockers and nitrates Vascular surgery should occur as soon as possible but no later than three months after randomization 2 Coronary artery revascularization Repair of the heart in patients with coronary artery disease may aid in the protection of these patients when they undergo vascular surgery The surgeon is free to choose between coronary artery bypass grafting CABG and percutaneous transluminal coronary angioplasty PTCA Coronary artery revascularization should occur as soon as possible after randomization Vascular surgery should occur between one and three months following CABG or between three to four days and three months following PTCA
Primary Outcomes Long-term mortality MI and quality of life
Study Abstract Cardiovascular disease accounts for one million deaths per year and is the major cause of mortality among Americans Studies have shown that in patients scheduled for elective vascular surgery the prevalence of coronary artery disease exceeds 50 It is not surprising therefore that perioperative cardiac morbidity defined as the occurrence of MI unstable angina CHF arrhythmias and cardiac death is the leading cause of perioperative complications Although a number of sophisticated diagnostic tests have been shown to be helpful in identifying patients at high risk for perioperative cardiac complications no study has addressed the most important question Should prophylactic coronary revascularization be performed prior to elective vascular surgery This study is designed to answer this question
STUDY DESIGN This proposal utilizes a prospective randomized trial to test whether prophylactic coronary revascularization reduces perioperative cardiac complications and long term mortality in patients who undergo elective vascular surgery All VA patients requiring elective vascular surgery will be screened for enrollment Patients will be excluded from enrollment if they need urgentemergent vascular surgery have had previous coronary artery revascularization with no current ischemia or have one or more serious medical conditions such as COPD FEV110 renal dysfunction creatinine 35 mgdl liver failure metastatic cancer severe dementia stroke or unstable angina Eligibility for the study is based on results from coronary angiography Patients having clinical risk factors including history of MI pathologic Q-waves ventricular ectopy requiring antiarrhythmic therapy diabetes angina and CHF andor a positive stress test should be candidates for coronary angiography Specific angiographic criteria will exclude individuals from subsequent randomization These include normal coronary arteries severe LV dysfunction EF20 aortic valve area 1 cm2 and left main disease or equivalent Patients considered nonintervenable by the cardiologist or cardiac surgeon will also be excluded Enrolled patients who do not meet any of the exclusion criteria will then be randomized to either medical treatment or prophylactic revascularization The decision to proceed with either PTCA or CABG will be based on institutional experiences The study design does not compare PTCA versus CABG but rather tests whether any revascularization procedure proves beneficial The stratification factors will be the participating hospital and the type of vascular procedure that has been proposed intraabdominal or infrainguinal The randomization scheme is stratified by type of vascular surgery because aortic procedures intraabdominal may carry more risk than peripheral procedures infrainguinal
STATISTICAL CONSIDERATIONS For this trial a sample size of 560 randomized patients will be required This will provide 90 power to detect a difference in 35 year survival rates of 85 for patients receiving prophylactic coronary artery revascularization versus 75 for patients receiving medical treatment Allowing for a 10 post randomization dropout rate the target sample size will be 620 patients Assuming an average intake of one patient per hospital per month 18 participating hospitals will be required
STUDY PHASES The study originally was funded for a one year pilot phase The purpose of this phase was to determine the feasibility of randomizing one patient per hospital per month In order for the study to enter the main phase five pilot hospitals ranging in number of vascular surgery cases from low to high had to achieve at least 90 of patient accrual expectations 54 out of an expected 60 patients randomized in one year After successful completion of the pilot phase the main study was approved During the main phase 18 participating hospitals will accrue patients for four years and continue postvascular surgery follow-up for one year
Secondary Hypotheses Prophylactic coronary artery revascularization in high risk patients scheduled for elective vascular surgery reduces long-term risk of myocardial infarction and improves both cost-effectiveness of treatment and quality of life of the patients
Intervention 1 Medical therapy This is the current conservative practice Each local investigator will decide the best medical treatment consistent with that given to any patient scheduled for elective vascular surgery In patients with coronary artery disease long-term treatment would be expected to include a combination of antiplatelet agents beta-blockers calcium channel blockers and nitrates Vascular surgery should occur as soon as possible but no later than three months after randomization 2 Coronary artery revascularization Repair of the heart in patients with coronary artery disease may aid in the protection of these patients when they undergo vascular surgery The surgeon is free to choose between coronary artery bypass grafting CABG and percutaneous transluminal coronary angioplasty PTCA Coronary artery revascularization should occur as soon as possible after randomization Vascular surgery should occur between one and three months following CABG or between three to four days and three months following PTCA
Primary Outcomes Long-term mortality MI and quality of life
Study Abstract Cardiovascular disease accounts for one million deaths per year and is the major cause of mortality among Americans Studies have shown that in patients scheduled for elective vascular surgery the prevalence of coronary artery disease exceeds 50 It is not surprising therefore that perioperative cardiac morbidity defined as the occurrence of MI unstable angina CHF arrhythmias and cardiac death is the leading cause of perioperative complications Although a number of sophisticated diagnostic tests have been shown to be helpful in identifying patients at high risk for perioperative cardiac complications no study has addressed the most important question Should prophylactic coronary revascularization be performed prior to elective vascular surgery This study is designed to answer this question
STUDY DESIGN This proposal utilizes a prospective randomized trial to test whether prophylactic coronary revascularization reduces perioperative cardiac complications and long term mortality in patients who undergo elective vascular surgery All VA patients requiring elective vascular surgery will be screened for enrollment Patients will be excluded from enrollment if they need urgentemergent vascular surgery have had previous coronary artery revascularization with no current ischemia or have one or more serious medical conditions such as COPD FEV110 renal dysfunction creatinine 35 mgdl liver failure metastatic cancer severe dementia stroke or unstable angina Eligibility for the study is based on results from coronary angiography Patients having clinical risk factors including history of MI pathologic Q-waves ventricular ectopy requiring antiarrhythmic therapy diabetes angina and CHF andor a positive stress test should be candidates for coronary angiography Specific angiographic criteria will exclude individuals from subsequent randomization These include normal coronary arteries severe LV dysfunction EF20 aortic valve area 1 cm2 and left main disease or equivalent Patients considered nonintervenable by the cardiologist or cardiac surgeon will also be excluded Enrolled patients who do not meet any of the exclusion criteria will then be randomized to either medical treatment or prophylactic revascularization The decision to proceed with either PTCA or CABG will be based on institutional experiences The study design does not compare PTCA versus CABG but rather tests whether any revascularization procedure proves beneficial The stratification factors will be the participating hospital and the type of vascular procedure that has been proposed intraabdominal or infrainguinal The randomization scheme is stratified by type of vascular surgery because aortic procedures intraabdominal may carry more risk than peripheral procedures infrainguinal
STATISTICAL CONSIDERATIONS For this trial a sample size of 560 randomized patients will be required This will provide 90 power to detect a difference in 35 year survival rates of 85 for patients receiving prophylactic coronary artery revascularization versus 75 for patients receiving medical treatment Allowing for a 10 post randomization dropout rate the target sample size will be 620 patients Assuming an average intake of one patient per hospital per month 18 participating hospitals will be required
STUDY PHASES The study originally was funded for a one year pilot phase The purpose of this phase was to determine the feasibility of randomizing one patient per hospital per month In order for the study to enter the main phase five pilot hospitals ranging in number of vascular surgery cases from low to high had to achieve at least 90 of patient accrual expectations 54 out of an expected 60 patients randomized in one year After successful completion of the pilot phase the main study was approved During the main phase 18 participating hospitals will accrue patients for four years and continue postvascular surgery follow-up for one year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None