Asymptomatic Cardiac Ischemia Pilot (ACIP) study: Impact of anti-ischemia therapy on 12-week rest electrocardiogram and exercise test outcomes. The ACIP Investigators

Division of Cardiology, Saint Louis University Health Sciences Center, Missouri 63110-0250, USA.
Journal of the American College of Cardiology (Impact Factor: 16.5). 09/1995; 26(3):585-593. DOI: 10.1016/0735-1097(95)00013-T


This study was funded by the National Heart, Lung, and Blood Institute, Cardiac Diseases Branch, Division of Heart and Vascular Diseases, National Institutes of Health, Bethesda, Maryland by research contracts HV-90-07, HV-90-08, HV-91-05 to HV-91-14. Study medications and placebo were donated by Zeneca Pharma Inc., Wilmington, Delaware; Marion-Merrell Dow, Kansas City, Missouri; and Pfizer, New York, New York. Support for exercise electrocardiographic data collection was provided in part by Marquette Electronics, Milwaukee, Wisconsin and by Quinton Instruments, Seattle, Washington. A list of participating centers and investigators for the ACIP study appears in reference 28.

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Available from: George Sopko, Dec 12, 2013
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    • "A bicycle ergometry stress test adapted from the Asymptomatic Cardiac Ischemia Pilot (ACIP) protocol [18] was selected because the incremental increases in exercise workload are more gradual (≤1.5 METS/stage) compared to the larger work demands inherent in other exercise testing protocols (for example, the Bruce protocol). In patients with advanced coronary artery disease, this approach provides a greater discrimination in defining the time to onset of 1 mm ST-segment depression, angina, and heart rate increase [19]. "
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    ABSTRACT: Background A growing population of patients lives with severe coronary artery disease not amenable to coronary revascularization and with refractory angina despite optimal medical therapy. Percutaneous reduction of the coronary sinus is an emerging treatment for myocardial ischemia that increases coronary sinus pressure to promote a transcollateral redistribution of coronary artery in-flow from nonischemic to ischemic subendocardial territories. A first-in-man study has demonstrated that the percutaneous reduction of the coronary sinus can be performed safely in such patients. The COSIRA trial seeks to assess whether a percutaneous reduction of the coronary sinus can improve the symptoms of refractory angina in patients with limited revascularization options. Methods/Design The COSIRA trial is a phase II double-blind, sham-controlled, randomized parallel trial comparing the percutaneously implanted coronary sinus Reducer (Neovasc Inc, Richmond, BC, Canada) to a sham implantation in 124 patients enrolled in Canada, Belgium, England, Scotland, Sweden and Denmark. All patients need to have stable Canadian Cardiovascular Society (CCS) class III or IV angina despite optimal medical therapy, with evidence of reversible ischemia related to disease in the left coronary artery, and a left ventricular ejection fraction >25%. Participants experiencing an improvement in their angina ≥2 CCS classes six months after the randomization will meet the primary efficacy endpoint. The secondary objective of this trial is to test whether coronary sinus Reducer implantation will improve left ventricular ischemia, as measured by the improvement in dobutamine echocardiogram wall motion score index and in time to 1 mm ST-segment depression from baseline to six-month post-implantation. Discussion Based on previous observations, the COSIRA is expected to provide a significant positive result or an informative null result upon which rational development decisions can be based. Patient safety is a central concern and extensive monitoring should allow an appropriate investigation of the safety related to the coronary sinus Reducer.
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    ABSTRACT: We examined the relation between anginal symptoms and ischemic indexes during ischemia on exercise testing and daily activities in 76 patients (59 men and 17 women, mean age 61.5 years) with documented coronary artery disease and exercise-induced ischemia. All patients underwent upright bicycle exercise testing and 48-hour ambulatory electrocardiographic monitoring (AECG). Angina was reported in 28 patients (37%) during exercise-induced ischemia. A total of 287 ischemic episodes were detected from 44 patients (58%) during AECG. There was a mean number of 7.4 episodes and a mean total duration of 75 min/48 hours. There were no differences in the prevalence and the magnitude of ambulatory ischemia between patients with and without angina during exercise testing. Among the 44 patients who had ischemia during both tests, 50% of patients with angina during exercise testing had symptomatic ischemia during AECG compared to 14% in patients with silent ischemia during exercise testing (p = 0.01). Ninety-two percent of ischemic episodes were preceded by an increase in heart rate (HR) of >10 beats/min. There was a strong positive correlation (r = 0.70, p
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    Full-text · Article · May 1996 · Journal of the American College of Cardiology
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