Effectiveness of Combining Beta-Blocker Therapy and a Pacemaker Following a Heart Attack (The PACE-MI Trial)

Condition(s) targeted: Myocardial Infarction; Bradycardia; Heart Block

Intervention: Implantable Pacemaker (Device); Metoprolol (Beta-Blocker Medication) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)

Official(s) and/or principal investigator(s):
Jeffrey Goldberger, MD, MBA, Principal Investigator, Affiliation: Northwestern University

Overall contact:
Charity Ball, RN, BSN, Phone: 312-926-5517, Email: c-ball@northwestern.edu

Beta-blockers are recommended to individuals who have recently had a heart attack. They are contraindicated for individuals with abnormally slow heart rates or significant conduction system disease; however, the addition of a pacemaker may make beta-blocker therapy safe for these individuals. This study will evaluate the effectiveness of a pacemaker combined with beta-blocker therapy at improving survival rates and preventing subsequent heart attacks in individuals with abnormally slow heart rates who have recently experienced a heart attack.

Official title: The PACE-MI Trial: PACEmaker and Beta-Blocker Therapy After Myocardial Infarction

Study design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Total mortality

Non-fatal subsequent heart attack

Secondary outcome:

Total and cardiac mortality (sudden or non-sudden)

Re-hospitalization due to subsequent heart attack, unstable angina, congestive heart failure, stroke, new onset atrial fibrillation, or sustained ventricular arrhythmias

Quality of life

Economics measures

Detailed description: Individuals who have had a heart attack are often prescribed beta-blocker medications, which decrease the heart's workload and help to regulate heart rate. Beta-blockers are considered very effective at improving survival and reducing the occurrence of future heart attacks. Currently, however, it is recommended that individuals with abnormally slow heart rates, known as bradycardia, not receive beta-blocker therapy because of the risk of developing a dangerously low heart rate. Pacemakers, which are small, implanted devices that help the heart to beat regularly and at an appropriate rate, provide heart rate support to make beta-blocker therapy safe for individuals with bradycardia. The purpose of this study is to evaluate the effectiveness of a pacemaker combined with beta-blocker therapy at improving the survival rate and preventing subsequent heart attacks in individuals with bradycardia who have recently experienced a heart attack.

Participants will include individuals who have had a recent heart attack and who have been withdrawn from beta-blocker therapy due to bradycardia symptoms or for whom beta-blocker therapy is contraindicated. Participants will be randomly assigned to either a usual care control group or a study treatment group. The treatment group will receive standard medical therapy, implantation of a pacemaker, and beta-blocker therapy. The control group will receive only standard medical therapy with no beta-blockers. Study visits for both groups will occur every 6 months for 2 years, and telephone follow-up calls will occur every 3 months until the end of the study. Participants' medical history, including medications and symptoms, as well as quality of life and economic factors will be assessed during the study visits and phone calls.

Individuals who meet the eligibility criteria and have relative contraindications to beta-blocker therapy will be enrolled in an observational group that will receive beta-blocker treatment. This group will be assessed during telephone calls every 3 months for the duration of the study.

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- History of a heart attack in the 90 days prior to study entry, as documented by both

of the following criteria:

1. Cardiac enzymes (creatine phosphokinase [CPK] elevation greater than two times the upper limit of normal or troponin elevation greater than three times the upper limit of normal)

2. Electrocardiographic changes and/or symptoms consistent with a heart attack (i. e., chest pain, shortness of breath)

- History of at least one of the following criteria:

1. Bradycardia or heart block that makes beta-blocker therapy medically unsafe, as defined by one of the following criteria:

1. Resting (awake) heart rate less than or equal to 55 beats per minute on 2 consecutive days in the absence of treatment with rate-slowing medications (i. e., diltiazem, verapamil)

2. Sinus pauses (greater than 2 seconds) during the day

3. PR interval of at least 260 msec in the absence of medications that prolong atrioventricular (AV) nodal conduction time (e. g., digoxin, diltiazem, verapamil)

4. Type I second-degree AV block at rest and while awake

2. Documented symptomatic bradycardia due to beta-blocker therapy

- Must provide written informed consent to participate in the study

Exclusion Criteria

- Unstable or class IV angina

- Unable to medically tolerate beta-blocker medications (i. e., severe bronchospastic

disease, systolic blood pressure less than 90 mm Hg)

- Requires either a pacemaker or implantable defibrillator or will require an

implantable defibrillator in the future

- Medically unable to receive a transvenous pacemaker (i. e., inadequate venous access,

bleeding disorder)

- Class IV New York Heart Association (NYHA) heart failure

- Scheduled for coronary artery bypass surgery within 3 months of study entry

- Undergone coronary artery bypass surgery within 2 weeks of study entry

- Marked valvular heart disease (i. e., greater than 3+ aortic or mitral insufficiency,

aortic stenosis with valve area less than 1 cm^2)

- Current alcohol or drug abuse

- Any medical condition that, in the investigators' judgment, would seriously limit life

expectancy (poor 6-month survival)

- Unavailable for follow-up for the duration of the study

- Currently participating in other clinical trials with an active treatment arm

(individuals who are participating in trials of diagnostic techniques or approved therapies are permitted to enroll)

- Unwilling or unable to provide informed consent

Charity Ball, RN, BSN, Phone: 312-926-5517, Email: c-ball@northwestern.edu

Hadassah Hospital, Jerusalem 91120, Israel; Recruiting
Keren Zylberman, Phone: 972-5-0244908
Shimon Rosenheck, MD, Principal Investigator

Sheba Medical Center, Tel Hashomer 52662, Israel; Recruiting
Nava Eizenberg, Phone: 972-3-5302617
Michael Eldar, MD, Principal Investigator

Tel-Aviv Sourasky Medical Center (TASMC), Tel Aviv 64239, Israel; Recruiting
Nurit Platner, Phone: 972-3-6973776
Sami Viskin, MD, Principal Investigator

University of Calgary, Calgary, Alberta T2N 4N1, Canada; Recruiting
Brenda Smith, Phone: 403-220-7668
J Wayne Warnica, MD, Principal Investigator

Little Rock Cardiology Clinic, Little Rock, Arkansas 72211, United States; Recruiting
Janae Tableriou, Phone: 501-614-3641
Scott Beau, MD, Principal Investigator

West Los Angeles VA Medical Center, Los Angeles, California 90073, United States; Recruiting
Janet Johnson, Phone: 310-478-3711, Ext: 48389
Alberta Warner, MD, Principal Investigator

Long Beach Memorial Medical Center, Long Beach, California 90801, United States; Recruiting
Joanne Morrison, Phone: 562-933-3204
John Messenger, MD, Principal Investigator

University of California at San Francisco, San Francisco, California 94143, United States; Recruiting
Deanna Green, Phone: 415-476-9128
Nitish Badhwar, MD, Principal Investigator

South Denver Cardiology, Littleton, Colorado 80120, United States; Recruiting
Delsa Rose, Phone: 303-703-2175
Srikanth Sundaram, MD, Principal Investigator

Yale University, New Haven, Connecticut 06520, United States; Recruiting
Rachel Lampert, Phone: 203-737-4068
Rachel Lampert, MD, Principal Investigator

Baptist Cardiac and Vascular Institute, Miami, Florida 33176, United States; Recruiting
Ivette Cruz, Phone: 786-596-4746
Efrain Gonzalez, MD, Principal Investigator

Mayo Clinic, Jacksonville, Florida 32224, United States; Recruiting
Barbara Little, Phone: 904-953-8361
Fred Kusumoto, MD, Principal Investigator

Orlando Regional Medical Center, Orlando, Florida 32806, United States; Recruiting
Shannon Harrison, Phone: 321-841-3688
David Bello, MD, Principal Investigator

Mercy Research Institute, Coconut Grove, Florida 33133, United States; Recruiting
Adriana Silva, Phone: 305-854-4400, Ext: 2495
Peter Garcia, MD, Principal Investigator

Fuqua Heart Center of Atlanta / Piedmont Hospital, Atlanta, Georgia 30309, United States; Recruiting
Kristi Picardi, Phone: 404-605-2409
Dan Dan, MD, Principal Investigator

Northwestern Memorial Hospital, Chicago, Illinois 60611, United States; Recruiting
Liz Karpf, Phone: 312-926-1096
Dan Fintel, MD, Principal Investigator

Clarian Health/Methodist Research Institute, Indianapolis, Indiana 46202, United States; Recruiting
Terri Strickland, Phone: 317-962-3586
Girish Nair, MD, MS, Principal Investigator

Henry Ford Hospital, Detroit, Michigan 48202, United States; Recruiting
Joan Dzidowski, Phone: 313-916-3766
Claudio Schuger, MD, Principal Investigator

St. John Hospital and Medical Center, Detroit, Michigan 48236, United States; Recruiting
Sherri Teller, Phone: 313-343-8335
Michael Romanelli, MD, Principal Investigator

Cardiovascular Medicine and Interventional Cardiology/Beaumont Hospital, Southfield, Michigan 48076, United States; Recruiting
Margaret Romanoski, Phone: 248-898-6602
Steven Timmis, MD, Principal Investigator

Park Nicollet, St. Louis Park, Minnesota 55426, United States; Recruiting
Sandy Barnes, Phone: 952-993-3982
Jay Simonson, MD, Principal Investigator

St. Luke's - Roosevelt Hospital, New York, New York 10025, United States; Recruiting
Robin Knox, Phone: 212-523-3253
Eyal Herzog, MD, Principal Investigator

Mount Sinai, New York, New York 10029, United States; Recruiting
Elena Pe, Phone: 212-241-7272
Davendra Mehta, MD, Principal Investigator

Winthrop University Hospital, Bethpage, New York 11714, United States; Recruiting
Wendy Drews, Phone: 516-663-2929
Joseph Germano, MD, Principal Investigator

Strong Memorial Hospital (University of Rochester School of Medicine), Rochester, New York 14642, United States; Recruiting
Vicki Conary-Rocco, Phone: 585-273-4956
Imran Chaudhary, MD, Principal Investigator

University of North Carolina, Chapel Hill, North Carolina 27599, United States; Recruiting
Carl Schuler, Phone: 919-843-4597
John Mounsey, MD, Principal Investigator

Riverside Methodist Hospital/Midwest Cardiology, Columbus, Ohio 43214, United States; Recruiting
Theresa Edwards, Phone: 614-566-1252
Allan Nichols, MD, Principal Investigator

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States; Recruiting
Genne Straughn, Phone: 405-271-2916, Ext: 44777
Robin Germany, MD, Principal Investigator

Baptist Memorial Hospital, Memphis, Tennessee 38120, United States; Recruiting
Teresa Bacon-Howard, Phone: 901-226-3874
Eric Johnson, MD, Principal Investigator

Amarillo Heart Clinic Research Institute, Inc., Amarillo, Texas 79106, United States; Recruiting
Mona Betzen, Phone: 806-463-2153, Ext: 417
Prakash Desai, MD, Principal Investigator

Austin Heart, Austin, Texas 78756, United States; Recruiting
Melissa Samendinger, Phone: 512-206-3614
Jeffrey Whitehill, MD, Principal Investigator

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229, United States; Recruiting
Judy Bolton, Phone: 210-567-6553
Manoj Panday, MD, Principal Investigator

Fletcher Allen Health Care, Burlington, Vermont 05401, United States; Recruiting
Michaelanne Rowen, Phone: 802-847-4746
Daniel Lustgarten, MD, Principal Investigator

University of Washington School of Medicine, Seattle, Washington 98195, United States; Recruiting
Alisa Clein, Phone: 206-616-3541
Robert Rho, MD, Principal Investigator

Marshfield Clinic, Marshfield, Wisconsin 54449, United States; Recruiting
Karen Maassen, Phone: 715-389-4773
John Hayes, MD, Principal Investigator

Click here for the PACE-MI Trial web site.

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Starting date: April 2007
Ending date: April 2010
Last updated: October 21, 2008