|
Does prophylactic coronary artery revascularization for high risk patients reduce long-term risk of mortality Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Does prophylactic coronary artery revascularization for high risk patients reduce long-term risk of mortality conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Does prophylactic coronary artery revascularization for high risk patients reduce long-term risk of mortality Clinical research trials and Does prophylactic coronary artery revascularization for high risk patients reduce long-term risk of mortality health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Does prophylactic coronary artery revascularization for high risk patients reduce long-term risk of mortality. Does prophylactic coronary artery revascularization for high risk patients reduce long-term risk of mortality Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Does prophylactic coronary artery revascularization for high risk patients reduce long-term risk of mortality clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Does prophylactic coronary artery revascularization for high risk patients reduce long-term risk of mortality condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "D" Clinical Trials Conditions > Does prophylactic coronary artery revascularization for high risk patients reduce long-term risk of mortality  Does prophylactic coronary artery revascularization for high risk patients reduce long-term risk of mortality
Does prophylactic coronary artery revascularization for high risk patients reduce long-term risk of mortality
For Condition: Cardiovascular Disease
Status: No longer recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program
Synopsis: 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.
Details: 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 urgent/emergent vascular surgery; have had previous coronary artery revascularization with no current ischemia; or have one or more serious medical conditions such as COPD (FEV1<1.0), renal dysfunction (creatinine >3.5 mg/dl), 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); and/or 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 (EF<20%), 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 3.5 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.
Eligibility:
Study Type: Interventional,Treatment,Randomized
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: High risk patients scheduled for elective vascular surgery
Total Enrollment: 560
Location and Contact Information:
Dallas VA Medical Center
Dallas, Texas, 75216
United States
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15240
United States
West LA VA Medical Center
Los Angeles, California, 90073
United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
United States
Albuquerque VA Medical Center
Albuquerque, New Mexico, 87108
United States
Central AR Veterans HCS
Little Rock, Arkansas, 72205-5484
United States
Tampa VA Medical Center
Tampa, Florida, 33612
United States
San Francisco VA Medical Center
San Francisco, California, 94121
United States
Gainesville VA Medical Center
Gainesville, Florida, 32608-1197
United States
Portland VA Medical Center
Portland, Oregon, 97201
United States
Durham VA Medical Center
Durham, North Carolina, 27705
United States
Puget Sound Health Care System
Seattle, Washington, 98108
United States
Cleveland VA Medical Center
Cleveland, Ohio, 44106
United States
Atlanta VA Medical Center
Atlanta, Georgia, 30033
United States
Denver VA Medical Center
Denver, Colorado, 80220
United States
Indianapolis VA Medical Center
Indianapolis, Indiana, 46202
United States
Tucson VA Medical Center
Tucson, Arizona, 85723
United States
San Antonio VA Medical Center
San Antonio, Texas, 78284
United States
Additional Information:
Study ID Numbers: 411;
Study Start Date: August 1997
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032370
Other Cardiovascular Disease Studies:
1. Heart Disease Risk Factors in Major Depression
2. Study of Inherited Changes of Receptors Located on Blood Vessels
3. Comparing Angiomax to Heparin with Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB)
4. Gender, Obesity, C-Reactive Protein, and Oxidative Stress
5. Metabolic Differences of Overweight Children and Children of Overweight Parents
Related Studies:
Other Cardiovascular Disease Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Does prophylactic coronary artery revascularization for high risk patients reduce long-term risk of mortality
|
|
|
|
|
|
|
|
