The Asymptomatic Cardiac Ischemia Pilot (ACIP) study: Design of a randomized clinical trial, baseline data and implications for a long-term outcome trial

Carl J. Pepine, Nancy L. Geller, Genell L. Knatterud, Martial G. Bourassa, Bernard R. Chaitman, Richard F. Davies, Philip Day, John E. Deanfield, A. David Goldberg, Robert P. McMahon, Hiltrud Mueller, Pamela Ouyang, Craig Pratt, Michael Proschan, William J. Rogers, Andrew P. Selwyn, Barry Sharaf, George Sopko, Peter H. Stone, C. Richard Conti

Research output: Contribution to journalArticle

Abstract

Objectives. The primary objectives of the Asymptomatic Cardiac Ischemia Pilot were 1) to compare the 12-week efficacy of three treatment strategies to suppress cardiac ischemia, and 2) to assess the feasibility of a prognosis trial in patients with asymptomatic cardiac ischemia. Background. Cardiac ischemia has been associated with increased morbidity and mortality. However, most cardiac ischemia is asymptomatic, and although therapeutic strategies ranging from no medication to revascularization are being used to treat ischemia, no prospective study evaluating different treatment strategies has been reported. Methods. Patients with angiographically documented coronary artery disease and ischemia on exercise and ambulatory electrocardiogram (ECG) in 11 clinical units were randomized to receive angina-guided medical therapy, angina-guided plus ambulatory ECG ischemia-guided medical therapy or revascularization (coronary angioplasty or bypass surgery). Patients were also randomized to receive either diltiazem plus isosorbide dinitrate or atenolol plus nifedipine when possible. After anti-ischemic medication adjustment to control angina, blinded medication was adjusted in the medical therapy groups to eliminate ischemia in the ischemia-guided group. The primary outcome was the absence of ischemia at 12 weeks. Follow-up was scheduled for 1 year. Results. A total of 1,959 patients were screened by ambulatory ECG monitoring; 982 (49%) had asymptomatic ischemia, and 618 (65%) were enrolled in the study. Most patients were men, were >60 years old and had two or more ischemic episodes, early positive exercise tests and multivessel disease. Conclusions. Design and baseline data for a pilot study of ischemia treatment strategies are described.

Original languageEnglish (US)
Pages (from-to)1-10
Number of pages10
JournalJournal of the American College of Cardiology
Volume24
Issue number1
DOIs
StatePublished - 1994
Externally publishedYes

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Ischemia
Randomized Controlled Trials
Electrocardiography
Isosorbide Dinitrate
Therapeutics
Social Adjustment
Ambulatory Monitoring
Atenolol
Diltiazem
Nifedipine
Group Psychotherapy
Exercise Test
Angioplasty
Coronary Artery Disease
Prospective Studies
Exercise
Morbidity
Mortality

ASJC Scopus subject areas

  • Nursing(all)

Cite this

The Asymptomatic Cardiac Ischemia Pilot (ACIP) study : Design of a randomized clinical trial, baseline data and implications for a long-term outcome trial. / Pepine, Carl J.; Geller, Nancy L.; Knatterud, Genell L.; Bourassa, Martial G.; Chaitman, Bernard R.; Davies, Richard F.; Day, Philip; Deanfield, John E.; Goldberg, A. David; McMahon, Robert P.; Mueller, Hiltrud; Ouyang, Pamela; Pratt, Craig; Proschan, Michael; Rogers, William J.; Selwyn, Andrew P.; Sharaf, Barry; Sopko, George; Stone, Peter H.; Conti, C. Richard.

In: Journal of the American College of Cardiology, Vol. 24, No. 1, 1994, p. 1-10.

Research output: Contribution to journalArticle

Pepine, CJ, Geller, NL, Knatterud, GL, Bourassa, MG, Chaitman, BR, Davies, RF, Day, P, Deanfield, JE, Goldberg, AD, McMahon, RP, Mueller, H, Ouyang, P, Pratt, C, Proschan, M, Rogers, WJ, Selwyn, AP, Sharaf, B, Sopko, G, Stone, PH & Conti, CR 1994, 'The Asymptomatic Cardiac Ischemia Pilot (ACIP) study: Design of a randomized clinical trial, baseline data and implications for a long-term outcome trial', Journal of the American College of Cardiology, vol. 24, no. 1, pp. 1-10. https://doi.org/10.1016/0735-1097(94)90534-7
Pepine, Carl J. ; Geller, Nancy L. ; Knatterud, Genell L. ; Bourassa, Martial G. ; Chaitman, Bernard R. ; Davies, Richard F. ; Day, Philip ; Deanfield, John E. ; Goldberg, A. David ; McMahon, Robert P. ; Mueller, Hiltrud ; Ouyang, Pamela ; Pratt, Craig ; Proschan, Michael ; Rogers, William J. ; Selwyn, Andrew P. ; Sharaf, Barry ; Sopko, George ; Stone, Peter H. ; Conti, C. Richard. / The Asymptomatic Cardiac Ischemia Pilot (ACIP) study : Design of a randomized clinical trial, baseline data and implications for a long-term outcome trial. In: Journal of the American College of Cardiology. 1994 ; Vol. 24, No. 1. pp. 1-10.
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abstract = "Objectives. The primary objectives of the Asymptomatic Cardiac Ischemia Pilot were 1) to compare the 12-week efficacy of three treatment strategies to suppress cardiac ischemia, and 2) to assess the feasibility of a prognosis trial in patients with asymptomatic cardiac ischemia. Background. Cardiac ischemia has been associated with increased morbidity and mortality. However, most cardiac ischemia is asymptomatic, and although therapeutic strategies ranging from no medication to revascularization are being used to treat ischemia, no prospective study evaluating different treatment strategies has been reported. Methods. Patients with angiographically documented coronary artery disease and ischemia on exercise and ambulatory electrocardiogram (ECG) in 11 clinical units were randomized to receive angina-guided medical therapy, angina-guided plus ambulatory ECG ischemia-guided medical therapy or revascularization (coronary angioplasty or bypass surgery). Patients were also randomized to receive either diltiazem plus isosorbide dinitrate or atenolol plus nifedipine when possible. After anti-ischemic medication adjustment to control angina, blinded medication was adjusted in the medical therapy groups to eliminate ischemia in the ischemia-guided group. The primary outcome was the absence of ischemia at 12 weeks. Follow-up was scheduled for 1 year. Results. A total of 1,959 patients were screened by ambulatory ECG monitoring; 982 (49{\%}) had asymptomatic ischemia, and 618 (65{\%}) were enrolled in the study. Most patients were men, were >60 years old and had two or more ischemic episodes, early positive exercise tests and multivessel disease. Conclusions. Design and baseline data for a pilot study of ischemia treatment strategies are described.",
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T1 - The Asymptomatic Cardiac Ischemia Pilot (ACIP) study

T2 - Design of a randomized clinical trial, baseline data and implications for a long-term outcome trial

AU - Pepine, Carl J.

AU - Geller, Nancy L.

AU - Knatterud, Genell L.

AU - Bourassa, Martial G.

AU - Chaitman, Bernard R.

AU - Davies, Richard F.

AU - Day, Philip

AU - Deanfield, John E.

AU - Goldberg, A. David

AU - McMahon, Robert P.

AU - Mueller, Hiltrud

AU - Ouyang, Pamela

AU - Pratt, Craig

AU - Proschan, Michael

AU - Rogers, William J.

AU - Selwyn, Andrew P.

AU - Sharaf, Barry

AU - Sopko, George

AU - Stone, Peter H.

AU - Conti, C. Richard

PY - 1994

Y1 - 1994

N2 - Objectives. The primary objectives of the Asymptomatic Cardiac Ischemia Pilot were 1) to compare the 12-week efficacy of three treatment strategies to suppress cardiac ischemia, and 2) to assess the feasibility of a prognosis trial in patients with asymptomatic cardiac ischemia. Background. Cardiac ischemia has been associated with increased morbidity and mortality. However, most cardiac ischemia is asymptomatic, and although therapeutic strategies ranging from no medication to revascularization are being used to treat ischemia, no prospective study evaluating different treatment strategies has been reported. Methods. Patients with angiographically documented coronary artery disease and ischemia on exercise and ambulatory electrocardiogram (ECG) in 11 clinical units were randomized to receive angina-guided medical therapy, angina-guided plus ambulatory ECG ischemia-guided medical therapy or revascularization (coronary angioplasty or bypass surgery). Patients were also randomized to receive either diltiazem plus isosorbide dinitrate or atenolol plus nifedipine when possible. After anti-ischemic medication adjustment to control angina, blinded medication was adjusted in the medical therapy groups to eliminate ischemia in the ischemia-guided group. The primary outcome was the absence of ischemia at 12 weeks. Follow-up was scheduled for 1 year. Results. A total of 1,959 patients were screened by ambulatory ECG monitoring; 982 (49%) had asymptomatic ischemia, and 618 (65%) were enrolled in the study. Most patients were men, were >60 years old and had two or more ischemic episodes, early positive exercise tests and multivessel disease. Conclusions. Design and baseline data for a pilot study of ischemia treatment strategies are described.

AB - Objectives. The primary objectives of the Asymptomatic Cardiac Ischemia Pilot were 1) to compare the 12-week efficacy of three treatment strategies to suppress cardiac ischemia, and 2) to assess the feasibility of a prognosis trial in patients with asymptomatic cardiac ischemia. Background. Cardiac ischemia has been associated with increased morbidity and mortality. However, most cardiac ischemia is asymptomatic, and although therapeutic strategies ranging from no medication to revascularization are being used to treat ischemia, no prospective study evaluating different treatment strategies has been reported. Methods. Patients with angiographically documented coronary artery disease and ischemia on exercise and ambulatory electrocardiogram (ECG) in 11 clinical units were randomized to receive angina-guided medical therapy, angina-guided plus ambulatory ECG ischemia-guided medical therapy or revascularization (coronary angioplasty or bypass surgery). Patients were also randomized to receive either diltiazem plus isosorbide dinitrate or atenolol plus nifedipine when possible. After anti-ischemic medication adjustment to control angina, blinded medication was adjusted in the medical therapy groups to eliminate ischemia in the ischemia-guided group. The primary outcome was the absence of ischemia at 12 weeks. Follow-up was scheduled for 1 year. Results. A total of 1,959 patients were screened by ambulatory ECG monitoring; 982 (49%) had asymptomatic ischemia, and 618 (65%) were enrolled in the study. Most patients were men, were >60 years old and had two or more ischemic episodes, early positive exercise tests and multivessel disease. Conclusions. Design and baseline data for a pilot study of ischemia treatment strategies are described.

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