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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Jeff Goldberger, Northwestern University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00430612
First Posted: February 2, 2007
Last Update Posted: May 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeff Goldberger, Northwestern University
  Purpose

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.


Condition
Myocardial Infarction

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The PACE-MI Registry Study - Outcomes of Beta-blocker Therapy After Myocardial Infarction (OBTAIN)

Resource links provided by NLM:


Further study details as provided by Jeff Goldberger, Northwestern University:

Primary Outcome Measures:
  • Total mortality at 2 years post myocardial infarction [ Time Frame: Measured at Years 1 and 2 ]

    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%)



Secondary Outcome Measures:
  • Total mortality - secondary analysis [ Time Frame: Measured at Year 1 and Year 2 ]

    Compare Kaplan-Meier survival curves for the following 2 beta-blocker dose groups:

    Very Low Dose (>0-25%) vs. High Dose (≥50%)



Estimated Enrollment: 6830
Study Start Date: May 2009
Estimated Study Completion Date: June 2016
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Non-voluntary registry of consecutive patients diagnosed as having a MI at each study site

Detailed Description:

Methods

All patients admitted to the coronary care areas with an acute myocardial infarction will be entered into the registry. At the time of discharge from the coronary care unit, clinical data will be entered. The registry will include approximately 6800 patients.

As there is no intervention in the registry, the data to be collected are standard for quality assurance purposes and cannot practicably be carried out without waivers of consent and HIPAA authorization, there will be no consent specifically for registry patients at baseline. Systems have been implemented to ensure the registry data will remain confidential. Sites have received IRB approval of waiver of consent and HIPAA for the baseline registry data.

Data to be collected will include demographic (including ethnic and race classifications according to NIH guidelines) data and information regarding the index myocardial infarction. Use of beta-blockers at discharge from the coronary care unit will be documented. In addition, beta-blocker use at hospital discharge will be noted. Data for the registry will be obtained from ER notes, admission notes, cardiac catheterization lab reports, medication lists, lab reports, and discharge summaries.

Follow-Up

Follow-up for registry patients will be conducted at year 1 and year 2 post-myocardial infarction. Data may be obtained via medical chart review, phone contact, and Social Security Death Index (SSDI). For follow-up information obtained via chart review or the SSDI, a detailed justification for waiver of HIPAA and consent requirements is attached to this protocol (see appendix 7). If phone contact is required with the patient, we are suggesting the following process:

  • A letter should be sent out to the patient approximately one week prior to the contact in which the rationale for the study will be provided, as well as a delineation of the patient's right to participate or not to participate (by either providing or not providing the requested information).
  • At telephone contact with the patient, the coordinator will document whether the patient consents to provide the information. If the patient consents, the coordinator will proceed to obtain the requested information.
  • In the event that the participating institution's IRB requires a written, signed consent for this verbal contact, a written consent form template (see appendix 3) is provided.

Data collected at follow-up interview will include vital status, beta-blocker use, other cardiac medications and any cardiovascular hospitalizations.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
non-voluntary registry of consecutive patients diagnosed as having a MI at each study site
Criteria

Inclusion Criteria

1. Consecutive patients admitted with a myocardial infarction documented by both of the following:

  1. cardiac enzymes (CPK elevation > two times or troponin elevation > three times the upper limit of normal for the lab)
  2. Electrocardiographic changes and/or symptoms consistent with myocardial infarction (i.e. chest pain, shortness of breath)

No Exclusion Criteria

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430612


  Show 23 Study Locations
Sponsors and Collaborators
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jeffrey Goldberger, MD, MBA Northwestern University
  More Information

Publications:
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.
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. Epub 2005 Jul 21.
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.
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. Epub 2007 Nov 2. Review.
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.
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.
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, Málaga 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.
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.
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.
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.
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.
A randomized trial of propranolol in patients with acute myocardial infarction. I. Mortality results. JAMA. 1982 Mar 26;247(12):1707-14.
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.
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.
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.
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.
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.
Hjalmarson A, Elmfeldt D, Herlitz J, Holmberg S, Málek I, Nyberg G, Rydén L, Swedberg K, Vedin A, Waagstein F, Waldenström A, Waldenström 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.
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.
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.
The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet. 1999 Jan 2;353(9146):9-13.
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.
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.
American Heart Association. Heart disease and stroke statistics-2009 update. Dallas: American Heart Association; 2009.
Dmitrienko A, Molenberghs G, Chuang-Stein C, Offen W. Analysis of clinical trials using SAS: A practical guide. Cary, NC: SAS Institute Inc.; 2005.
Westfall PH. Multiple comparisons and multiple tests : using the SAS system. 1. print. ed. Cary NC: SAS Inst.; 1999.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeff Goldberger, Principal Investigator, MD, MBA, Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT00430612     History of Changes
Other Study ID Numbers: 469
U01HL080416 ( U.S. NIH Grant/Contract )
R01 HL080416-01A1
First Submitted: January 31, 2007
First Posted: February 2, 2007
Last Update Posted: May 1, 2015
Last Verified: April 2015

Keywords provided by Jeff Goldberger, Northwestern University:
Myocardial Infarction
Heart Attack
Beta Blockers
Survival

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs


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