Asymptomatic Cardiac Ischemia Pilot (ACIP) Study

NCT00000478 | Completed Phase 3

• 1 other identifier: 67
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the feasibility of and test the methodology for a full-scale clinical trial of therapies for asymptomatic cardiac ischemia.

Conditions

Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia

Interventions

atenolol DRUG

nifedipine DRUG

diltiazem DRUG

isosorbide dinitrate DRUG

coronary artery bypass coronary artery bypass PROCEDURE

angioplasty, transluminal, percutaneous coronary PROCEDURE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Men aand women with angiographically documented coronary artery disease, ischemia on both stress (exercise) testing and 48-hour ambulatory electrocardiogram monitoring, and who were amenable to revascularization.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (29)

• Pepine CJ, Geller NL, Knatterud GL, Bourassa MG, Chaitman BR, Davies RF, Day P, Deanfield JE, Goldberg AD, McMahon RP, et al. The Asymptomatic Cardiac Ischemia Pilot (ACIP) study: design of a randomized clinical trial, baseline data and implications for a long-term outcome trial. J Am Coll Cardiol. 1994 Jul;24(1):1-10. doi: 10.1016/0735-1097(94)90534-7.

  PMID: 8006249 BACKGROUND

• Knatterud GL, Bourassa MG, Pepine CJ, Geller NL, Sopko G, Chaitman BR, Pratt C, Stone PH, Davies RF, Rogers WJ, et al. Effects of treatment strategies to suppress ischemia in patients with coronary artery disease: 12-week results of the Asymptomatic Cardiac Ischemia Pilot (ACIP) study. J Am Coll Cardiol. 1994 Jul;24(1):11-20. doi: 10.1016/0735-1097(94)90535-5.

  PMID: 8006252 BACKGROUND

• Deedwania PC. Is there evidence in support of the ischemia suppression hypothesis? J Am Coll Cardiol. 1994 Jul;24(1):21-4. doi: 10.1016/0735-1097(94)90536-3. No abstract available.

  PMID: 8006267 BACKGROUND

• McMahon RP, Proschan M, Geller NL, Stone PH, Sopko G. Sample size calculation for clinical trials in which entry criteria and outcomes are counts of events. ACIP Investigators. Asymptomatic Cardiac Ischemia Pilot. Stat Med. 1994 Apr 30;13(8):859-70. doi: 10.1002/sim.4780130806.

  PMID: 8047740 BACKGROUND

• Tamesis B, Stelken A, Byers S, Shaw L, Younis L, Miller DD, Chaitman BR. Comparison of the Asymptomatic Cardiac Ischemia Pilot and modified Asymptomatic Cardiac Ischemia Pilot versus Bruce and Cornell exercise protocols. Am J Cardiol. 1993 Sep 15;72(9):715-20. doi: 10.1016/0002-9149(93)90891-f.

  PMID: 8249851 BACKGROUND

• Chaitman BR, Stone PH, Knatterud GL, Forman SA, Sopko G, Bourassa MG, Pratt C, Rogers WJ, Pepine CJ, Conti CR. Asymptomatic Cardiac Ischemia Pilot (ACIP) study: impact of anti-ischemia therapy on 12-week rest electrocardiogram and exercise test outcomes. The ACIP Investigators. J Am Coll Cardiol. 1995 Sep;26(3):585-93. doi: 10.1016/0735-1097(95)00013-t.

  PMID: 7642847 BACKGROUND

• Bourassa MG, Pepine CJ, Forman SA, Rogers WJ, Dyrda I, Stone PH, Chaitman BR, Sharaf B, Mahmarian J, Davies RF, et al. Asymptomatic Cardiac Ischemia Pilot (ACIP) study: effects of coronary angioplasty and coronary artery bypass graft surgery on recurrent angina and ischemia. The ACIP investigators. J Am Coll Cardiol. 1995 Sep;26(3):606-14. doi: 10.1016/0735-1097(95)00005-o.

  PMID: 7642849 BACKGROUND

• Conti RC, Kantterud GL, Sopko G: Correction. Letter to Editor. J Am Coll Cardiol 26:842, 1995

  BACKGROUND

• Caracciolo EA, Chaitman BR, Forman SA, Stone PH, Bourassa MG, Sopko G, Geller NL, Conti CR. Diabetics with coronary disease have a prevalence of asymptomatic ischemia during exercise treadmill testing and ambulatory ischemia monitoring similar to that of nondiabetic patients. An ACIP database study. ACIP Investigators. Asymptomatic Cardiac Ischemia Pilot Investigators. Circulation. 1996 Jun 15;93(12):2097-105. doi: 10.1161/01.cir.93.12.2097.

  PMID: 8925577 BACKGROUND

• Bourassa MG, Knatterud GL, Pepine CJ, Sopko G, Rogers WJ, Geller NL, Dyrda I, Forman SA, Chaitman BR, Sharaf B, et al. Asymptomatic Cardiac Ischemia Pilot (ACIP) Study. Improvement of cardiac ischemia at 1 year after PTCA and CABG. Circulation. 1995 Nov 1;92(9 Suppl):II1-7. doi: 10.1161/01.cir.92.9.1.

  PMID: 7586390 BACKGROUND

• Pratt CM, McMahon RP, Goldstein S, Pepine CJ, Andrews TC, Dyrda I, Frishman WH, Geller NL, Hill JA, Morgan NA, Stone PH, Knatterud GL, Sopko G, Conti CR. Comparison of subgroups assigned to medical regimens used to suppress cardiac ischemia (the Asymptomatic Cardiac Ischemia Pilot [ACIP] Study). Am J Cardiol. 1996 Jun 15;77(15):1302-9. doi: 10.1016/s0002-9149(96)00196-8.

  PMID: 8677870 BACKGROUND

• Pepine CJ, Andrews T, Deanfield JE, Forman S, Geller N, Hill JA, Pratt C, Rogers WJ, Sopko G, Steingart R, Stone PH, Conti CR. Relation of patient characteristics to cardiac ischemia during daily life activity (an Asymptomatic Cardiac Ischemia Pilot Data Bank Study). Am J Cardiol. 1996 Jun 15;77(15):1267-72. doi: 10.1016/s0002-9149(96)00190-7.

  PMID: 8677864 BACKGROUND

• Conti CR, Bourassa MG, Chaitman BR, Geller NL, Knatterud GL, Pepine CJ, Pratt C, Sopko G. Asymptomatic cardiac ischemia pilot (ACIP). Trans Am Clin Climatol Assoc. 1995;106:77-83; discussion 83-4.

  PMID: 7483181 BACKGROUND

• Stone PH, Chaitman BR, McMahon RP, Andrews TC, MacCallum G, Sharaf B, Frishman W, Deanfield JE, Sopko G, Pratt C, Goldberg AD, Rogers WJ, Hill J, Proschan M, Pepine CJ, Bourassa MG, Conti CR. Asymptomatic Cardiac Ischemia Pilot (ACIP) Study. Relationship between exercise-induced and ambulatory ischemia in patients with stable coronary disease. Circulation. 1996 Oct 1;94(7):1537-44. doi: 10.1161/01.cir.94.7.1537.

  PMID: 8840841 BACKGROUND

• Sharaf BL, Williams DO, Miele NJ, McMahon RP, Stone PH, Bjerregaard P, Davies R, Goldberg AD, Parks M, Pepine CJ, Sopko G, Conti CR. A detailed angiographic analysis of patients with ambulatory electrocardiographic ischemia: results from the Asymptomatic Cardiac Ischemia Pilot (ACIP) study angiographic core laboratory. J Am Coll Cardiol. 1997 Jan;29(1):78-84. doi: 10.1016/s0735-1097(96)00444-5.

  PMID: 8996298 BACKGROUND

• Davies RF, Goldberg AD, Forman S, Pepine CJ, Knatterud GL, Geller N, Sopko G, Pratt C, Deanfield J, Conti CR. Asymptomatic Cardiac Ischemia Pilot (ACIP) study two-year follow-up: outcomes of patients randomized to initial strategies of medical therapy versus revascularization. Circulation. 1997 Apr 15;95(8):2037-43. doi: 10.1161/01.cir.95.8.2037.

  PMID: 9133513 BACKGROUND

• Conti CR, Geller NL, Knatterud GL, Forman SA, Pratt CM, Pepine CJ, Sopko G. Anginal status and prediction of cardiac events in patients enrolled in the asymptomatic cardiac ischemia pilot (ACIP) study. ACIP investigators. Am J Cardiol. 1997 Apr 1;79(7):889-92. doi: 10.1016/s0002-9149(97)00009-x.

  PMID: 9104900 BACKGROUND

• Pepine CJ, Sharaf B, Andrews TC, Forman S, Geller N, Knatterud G, Mahmarian J, Ouyang P, Rogers WJ, Sopko G, Steingart R, Stone PH, Conti CR. Relation between clinical, angiographic and ischemic findings at baseline and ischemia-related adverse outcomes at 1 year in the Asymptomatic Cardiac Ischemia Pilot study. ACIP Study Group. J Am Coll Cardiol. 1997 Jun;29(7):1483-9. doi: 10.1016/s0735-1097(97)00083-1.

  PMID: 9180108 BACKGROUND

• Steingart RM, Forman S, Coglianese M, Bittner V, Mueller H, Frishman W, Handberg E, Gambino A, Knatterud G, Conti CR. Factors limiting the enrollment of women in a randomized coronary artery disease trial. The Asymptomatic Cardiac Ischemia Pilot Study (ACIP) Investigators. Clin Cardiol. 1996 Aug;19(8):614-8. doi: 10.1002/clc.4960190807.

  PMID: 8864334 BACKGROUND

• Stone PH, Chaitman BR, Forman S, Andrews TC, Bittner V, Bourassa MG, Davies RF, Deanfield JE, Frishman W, Goldberg AD, MacCallum G, Ouyang P, Pepine CJ, Pratt CM, Sharaf B, Steingart R, Knatterud GL, Sopko G, Conti CR. Prognostic significance of myocardial ischemia detected by ambulatory electrocardiography, exercise treadmill testing, and electrocardiogram at rest to predict cardiac events by one year (the Asymptomatic Cardiac Ischemia Pilot [ACIP] study). Am J Cardiol. 1997 Dec 1;80(11):1395-401. doi: 10.1016/s0002-9149(97)00706-6.

  PMID: 9399710 BACKGROUND

• Mahmarian JJ, Steingart RM, Forman S, Sharaf BL, Coglianese ME, Miller DD, Pepine CJ, Goldberg AD, Bloom MF, Byers S, Dvorak L, Pratt CM. Relation between ambulatory electrocardiographic monitoring and myocardial perfusion imaging to detect coronary artery disease and myocardial ischemia: an ACIP ancillary study. The Asymptomatic Cardiac Ischemia Pilot (ACIP) Investigators. J Am Coll Cardiol. 1997 Mar 15;29(4):764-9. doi: 10.1016/s0735-1097(96)00572-4.

  PMID: 9091522 BACKGROUND

• Rogers WJ, Bourassa MG, Andrews TC, Bertolet BD, Blumenthal RS, Chaitman BR, Forman SA, Geller NL, Goldberg AD, Habib GB, et al. Asymptomatic Cardiac Ischemia Pilot (ACIP) study: outcome at 1 year for patients with asymptomatic cardiac ischemia randomized to medical therapy or revascularization. The ACIP Investigators. J Am Coll Cardiol. 1995 Sep;26(3):594-605. doi: 10.1016/0735-1097(95)00228-v.

  PMID: 7642848 BACKGROUND

• Pepine CJ, Bourassa MG, Chaitman BR, Davies RF, Kerensky RA, Sharaf B, Knatterud GL, Forman SA, Pratt CM, Staples ED, Sopko G, Conti CR. Factors influencing clinical outcomes after revascularization in the asymptomatic cardiac ischemia pilot (ACIP). ACIP Study Group. J Card Surg. 1999 Jan-Feb;14(1):1-8. doi: 10.1111/j.1540-8191.1999.tb00943.x.

  PMID: 10678439 BACKGROUND

• Pepine CJ, Mark DB, Bourassa MG, Chaitman BR, Davies RF, Knatterud GL, Forman S, Pratt CM, Sopko G, Conti CR. Cost estimates for treatment of cardiac ischemia (from the Asymptomatic Cardiac Ischemia Pilot [ACIP] study). Am J Cardiol. 1999 Dec 1;84(11):1311-6. doi: 10.1016/s0002-9149(99)00563-9.

  PMID: 10614796 BACKGROUND

• Frishman WH, Gomberg-Maitland M, Hirsch H, Catanese J, Furia-Palazzo S, Mueller H, Steingart R, Forman S. Differences between male and female patients with regard to baseline demographics and clinical outcomes in the Asymptomatic Cardiac Ischemia Pilot (ACIP) Trial. Clin Cardiol. 1998 Mar;21(3):184-90. doi: 10.1002/clc.4960210310.

  PMID: 9541762 BACKGROUND

• Handberg-Thurmond E, Baker A, Coglianese ME, Forman S, Pepine CJ, Geller N, Chaitman B. Identifying high yield sources of patients with coronary artery disease for clinical trials: lessons from the Asymptomatic Cardiac Ischemia Pilot (ACIP) experience. The ACIP Study Group. Clin Cardiol. 1998 Mar;21(3):177-82. doi: 10.1002/clc.4960210308.

  PMID: 9541761 BACKGROUND

• Davies RF. The need for a prognosis trial of revascularization and aggressive medical therapy in patients with asymptomatic cardiac ischemia. ACIP Investigators. Asymptomatic Cardiac Ischemia Pilot. Clin Cardiol. 1998 Mar;21(3):154-6. doi: 10.1002/clc.4960210303. No abstract available.

  PMID: 9541757 BACKGROUND

• Sharaf BL, Bourassa MG, McMahon RP, Pepine CJ, Chaitman BR, Williams DO, Davies RF, Proschan M, Conti CR. Clinical and detailed angiographic findings in patients with ambulatory electrocardiographic ischemia without critical coronary narrowing: results from the Asymptomatic Cardiac Ischemia Pilot (ACIP) Study. Clin Cardiol. 1998 Feb;21(2):86-92. doi: 10.1002/clc.4960210205.

  PMID: 9491946 BACKGROUND

• Asymptomatic Cardiac Ischemia Pilot study (ACIP). Am J Cardiol. 1992 Sep 15;70(7):744-7. doi: 10.1016/0002-9149(92)90552-a.

  PMID: 1519524 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia

Interventions

Atenolol; Nifedipine; Diltiazem; Isosorbide Dinitrate; Coronary Artery Bypass; Angioplasty, Balloon, Coronary

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Isosorbide; Sorbitol; Sugar Alcohols; Carbohydrates; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures; Angioplasty, Balloon; Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Jerome Cohen

  St. Louis University

• Richard Davies

  University of Ottawa

• John Deanfield

  St. Bartholomew's Hospital, University of London

• Mark Ketterer

  Henry Ford Hospital

• Genell Knatterud

• Hiltrud Mueller

  Montefiore Medical Center

• Pamela Ouyang

  Johns Hopkins University

• Carl Pepine

  University of Florida

• Craig Pratt

  Baylor College of Medicine

• William Rogers

  University of Alabama at Birmingham

• Andrew Selwyn

  Brigham and Women's Hospital

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: November 1, 1990
• Study Completion: June 1, 1997
• Last Updated: March 25, 2016

Record last verified: 2002-02