The PACE-MI Registry Study - Outcomes of Beta-blocker Therapy After Myocardial Infarction (OBTAIN)

NCT00430612 | Completed DMC

• 2 other identifiers: 469U01HL080416
• Study Type: observational
• Target: 7,057
• Locations: 2 countries
• Sites: 23

Brief Summary

The purpose of the PACE-MI (OBTAIN) registry is:

• Analyze beta-blocker dose response effect on outcome over two years
• Explore gender and minority differences in beta-blocker utilization and outcomes. In patients with Myocardial Infarction (MI) discharged from the hospital, beta-blocker dose will be predictive of survival. Exploratory analyses: Gender and racial effects-gender and race are, similarly, hypothesized to be predictive of post-MI survival. The existence of interactions between gender and beta-blocker effect as well as race and beta-blocker effect will also be evaluated.

Conditions

Myocardial Infarction

Keywords

Myocardial Infarction; Heart Attack; Beta Blockers; Survival

Outcome Measures

Primary Outcomes (1)

• Total mortality at 2 years post myocardial infarction

  Compare Kaplan Meier survival curves for the following 5 beta-blocker dose groups: No beta-blockers - 12.5% (\>0 - 12.5%) 25% (\>12.5 - 25%) - 50% (\>25 - 50%) Full Dose (\>50%)

  Measured at Years 1 and 2

Secondary Outcomes (1)

• Total mortality - secondary analysis

  Measured at Year 1 and Year 2

Study Arms (1)

All Registry Participants

Non-voluntary registry of consecutive patients diagnosed as having a MI at each study site.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

non-voluntary registry of consecutive patients diagnosed as having a MI at each study site

You may qualify if:

• \. Consecutive patients admitted with a myocardial infarction documented by both of the following:
• cardiac enzymes (CPK elevation \> two times or troponin elevation \> three times the upper limit of normal for the lab)
• Electrocardiographic changes and/or symptoms consistent with myocardial infarction (i.e. chest pain, shortness of breath)

Sponsors & Collaborators

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

Study Sites (23)

Little Rock Cardiology Clinic

Little Rock, Arkansas, 72211, United States

Location

MemorialCare Heart and Vascular Institute - Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

West Los Angeles VA Medical Center

Los Angeles, California, 90073, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Clarian Health/Methodist Research Institute

Indianapolis, Indiana, 46202, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Park Nicollet

Saint Louis Park, Minnesota, 55426, United States

Location

Winthrop University Hospital

Bethpage, New York, 11714, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Strong Memorial Hospital (University of Rochester School of Medicine)

Rochester, New York, 14642, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Amarillo Heart Clinic Research Institute, Inc.

Amarillo, Texas, 79106, United States

Location

Austin Heart PLLC

Austin, Texas, 78756, United States

Location

Providence Health Center

Waco, Texas, 76712, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

Related Publications (28)

• Wikstrand J, Hjalmarson A, Waagstein F, Fagerberg B, Goldstein S, Kjekshus J, Wedel H; MERIT-HF Study Group. Dose of metoprolol CR/XL and clinical outcomes in patients with heart failure: analysis of the experience in metoprolol CR/XL randomized intervention trial in chronic heart failure (MERIT-HF). J Am Coll Cardiol. 2002 Aug 7;40(3):491-8. doi: 10.1016/s0735-1097(02)01970-8.

  PMID: 12142116 BACKGROUND

• Metra M, Torp-Pedersen C, Swedberg K, Cleland JG, Di Lenarda A, Komajda M, Remme WJ, Lutiger B, Scherhag A, Lukas MA, Charlesworth A, Poole-Wilson PA. Influence of heart rate, blood pressure, and beta-blocker dose on outcome and the differences in outcome between carvedilol and metoprolol tartrate in patients with chronic heart failure: results from the COMET trial. Eur Heart J. 2005 Nov;26(21):2259-68. doi: 10.1093/eurheartj/ehi386. Epub 2005 Jul 21.

  PMID: 16040619 BACKGROUND

• Dobre D, van Veldhuisen DJ, Mordenti G, Vintila M, Haaijer-Ruskamp FM, Coats AJ, Poole-Wilson PA, Flather MD; SENIORS Investigators. Tolerability and dose-related effects of nebivolol in elderly patients with heart failure: data from the Study of the Effects of Nebivolol Intervention on Outcomes and Rehospitalisation in Seniors with Heart Failure (SENIORS) trial. Am Heart J. 2007 Jul;154(1):109-15. doi: 10.1016/j.ahj.2007.03.025.

  PMID: 17584562 BACKGROUND

• Cucherat M. Quantitative relationship between resting heart rate reduction and magnitude of clinical benefits in post-myocardial infarction: a meta-regression of randomized clinical trials. Eur Heart J. 2007 Dec;28(24):3012-9. doi: 10.1093/eurheartj/ehm489. Epub 2007 Nov 2.

  PMID: 17981830 BACKGROUND

• Kjekshus JK. Importance of heart rate in determining beta-blocker efficacy in acute and long-term acute myocardial infarction intervention trials. Am J Cardiol. 1986 Apr 25;57(12):43F-49F. doi: 10.1016/0002-9149(86)90888-x.

  PMID: 2871745 BACKGROUND

• Chen ZM, Pan HC, Chen YP, Peto R, Collins R, Jiang LX, Xie JX, Liu LS; COMMIT (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) collaborative group. Early intravenous then oral metoprolol in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet. 2005 Nov 5;366(9497):1622-32. doi: 10.1016/S0140-6736(05)67661-1.

  PMID: 16271643 BACKGROUND

• POISE Study Group; Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, Xavier D, Chrolavicius S, Greenspan L, Pogue J, Pais P, Liu L, Xu S, Malaga G, Avezum A, Chan M, Montori VM, Jacka M, Choi P. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008 May 31;371(9627):1839-47. doi: 10.1016/S0140-6736(08)60601-7. Epub 2008 May 12.

  PMID: 18479744 BACKGROUND

• Gottlieb S, Harpaz D, Shotan A, Boyko V, Leor J, Cohen M, Mandelzweig L, Mazouz B, Stern S, Behar S. Sex differences in management and outcome after acute myocardial infarction in the 1990s: A prospective observational community-based study. Israeli Thrombolytic Survey Group. Circulation. 2000 Nov 14;102(20):2484-90. doi: 10.1161/01.cir.102.20.2484.

  PMID: 11076821 BACKGROUND

• Wilkinson P, Laji K, Ranjadayalan K, Parsons L, Timmis AD. Acute myocardial infarction in women: survival analysis in first six months. BMJ. 1994 Sep 3;309(6954):566-9. doi: 10.1136/bmj.309.6954.566.

  PMID: 7916229 BACKGROUND

• Mahon NG, McKenna CJ, Codd MB, O'Rorke C, McCann HA, Sugrue DD. Gender differences in the management and outcome of acute myocardial infarction in unselected patients in the thrombolytic era. Am J Cardiol. 2000 Apr 15;85(8):921-6. doi: 10.1016/s0002-9149(99)00902-9.

  PMID: 10760327 BACKGROUND

• Vaccarino V, Krumholz HM, Yarzebski J, Gore JM, Goldberg RJ. Sex differences in 2-year mortality after hospital discharge for myocardial infarction. Ann Intern Med. 2001 Feb 6;134(3):173-81. doi: 10.7326/0003-4819-134-3-200102060-00007.

  PMID: 11177329 BACKGROUND

• A randomized trial of propranolol in patients with acute myocardial infarction. I. Mortality results. JAMA. 1982 Mar 26;247(12):1707-14. doi: 10.1001/jama.1982.03320370021023.

  PMID: 7038157 BACKGROUND

• Olsson G, Wikstrand J, Warnold I, Manger Cats V, McBoyle D, Herlitz J, Hjalmarson A, Sonneblick EH. Metoprolol-induced reduction in postinfarction mortality: pooled results from five double-blind randomized trials. Eur Heart J. 1992 Jan;13(1):28-32. doi: 10.1093/oxfordjournals.eurheartj.a060043.

  PMID: 1533587 BACKGROUND

• Rochon PA, Anderson GM, Tu JV, Clark JP, Gurwitz JH, Szalai JP, Lau P. Use of beta-blocker therapy in older patients after acute myocardial infarction in Ontario. CMAJ. 1999 Nov 30;161(11):1403-8.

  PMID: 10906894 BACKGROUND

• Soumerai SB, McLaughlin TJ, Spiegelman D, Hertzmark E, Thibault G, Goldman L. Adverse outcomes of underuse of beta-blockers in elderly survivors of acute myocardial infarction. JAMA. 1997 Jan 8;277(2):115-21.

  PMID: 8990335 BACKGROUND

• Gottlieb SS, McCarter RJ, Vogel RA. Effect of beta-blockade on mortality among high-risk and low-risk patients after myocardial infarction. N Engl J Med. 1998 Aug 20;339(8):489-97. doi: 10.1056/NEJM199808203390801.

  PMID: 9709041 BACKGROUND

• Haywood LJ. Coronary heart disease mortality/morbidity and risk in blacks. I: Clinical manifestations and diagnostic criteria: the experience with the Beta Blocker Heart Attack Trial. Am Heart J. 1984 Sep;108(3 Pt 2):787-93. doi: 10.1016/0002-8703(84)90672-0.

  PMID: 6148005 BACKGROUND

• Hjalmarson A, Elmfeldt D, Herlitz J, Holmberg S, Malek I, Nyberg G, Ryden L, Swedberg K, Vedin A, Waagstein F, Waldenstrom A, Waldenstrom J, Wedel H, Wilhelmsen L, Wilhelmsson C. Effect on mortality of metoprolol in acute myocardial infarction. A double-blind randomised trial. Lancet. 1981 Oct 17;2(8251):823-7. doi: 10.1016/s0140-6736(81)91101-6.

  PMID: 6116950 BACKGROUND

• Norwegian Multicenter Study Group. Timolol-induced reduction in mortality and reinfarction in patients surviving acute myocardial infarction. N Engl J Med. 1981 Apr 2;304(14):801-7. doi: 10.1056/NEJM198104023041401.

  PMID: 7010157 BACKGROUND

• Viskin S, Kitzis I, Lev E, Zak Z, Heller K, Villa Y, Zajarias A, Laniado S, Belhassen B. Treatment with beta-adrenergic blocking agents after myocardial infarction: from randomized trials to clinical practice. J Am Coll Cardiol. 1995 May;25(6):1327-32. doi: 10.1016/0735-1097(94)00552-2.

  PMID: 7722129 BACKGROUND

• The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet. 1999 Jan 2;353(9146):9-13.

  PMID: 10023943 BACKGROUND

• Dargie HJ. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet. 2001 May 5;357(9266):1385-90. doi: 10.1016/s0140-6736(00)04560-8.

  PMID: 11356434 BACKGROUND

• Metoprolol in acute myocardial infarction (MIAMI). A randomised placebo-controlled international trial. The MIAMI Trial Research Group. Eur Heart J. 1985 Mar;6(3):199-226.

  PMID: 2863148 BACKGROUND

• American Heart Association. Heart disease and stroke statistics-2009 update. Dallas: American Heart Association; 2009.

  BACKGROUND

• Dmitrienko A, Molenberghs G, Chuang-Stein C, Offen W. Analysis of clinical trials using SAS: A practical guide. Cary, NC: SAS Institute Inc.; 2005.

  BACKGROUND

• Westfall PH. Multiple comparisons and multiple tests : using the SAS system. 1. print. ed. Cary NC: SAS Inst.; 1999.

  BACKGROUND

• Tu JV, Willison DJ, Silver FL, Fang J, Richards JA, Laupacis A, Kapral MK; Investigators in the Registry of the Canadian Stroke Network. Impracticability of informed consent in the Registry of the Canadian Stroke Network. N Engl J Med. 2004 Apr 1;350(14):1414-21. doi: 10.1056/NEJMsa031697.

  PMID: 15070791 BACKGROUND

• Goldberger JJ, Bonow RO, Cuffe M, Liu L, Rosenberg Y, Shah PK, Smith SC Jr, Subacius H; OBTAIN Investigators. Effect of Beta-Blocker Dose on Survival After Acute Myocardial Infarction. J Am Coll Cardiol. 2015 Sep 29;66(13):1431-41. doi: 10.1016/j.jacc.2015.07.047.

  PMID: 26403339 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Jeffrey Goldberger, MD, MBA

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, MBA, Professor of Medicine

Study Record Dates

• First Submitted: January 31, 2007
• First Posted: February 2, 2007
• Study Start: May 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: October 1, 2015
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

US (22); CA (1)