Heart Disease - Clinical Trials
What is MAGIC?
Magnesium in Coronaries (MAGIC)
is an international multicenter clinical trial sponsored by the National Heart,
Lung, and Blood Institute. This study is designed to evaluate whether giving
intravenous magnesium sulfate to high-risk patients early in the course of a
myocardial infarction (heart attack) will result in better survival.
What is magnesium sulfate?
Magnesium sulfate is an electrolyte solution which is FDA-approved to replace
magnesium in patients with low levels of this essential compound in their blood.
A large body of experimental evidence suggests that administering magnesium
sulfate may be beneficial in patients experiencing a heart attack, if it is
given prior to the reopening of the blocked artery.
Potential benefits:
Lower risk of death, heart failure, and serious heart rhythm disturbances
Potential risks:
Higher risk of slow heart rate, low blood pressure, and a flushing sensation
during the infusion of magnesium sulfate.
Patient Recruitment
10,400 patients at several hundred sites will be enrolled in the MAGIC trial. These patients will be
followed while in the hospital, and their vital status will be assessed 30 days
after enrollment. The first patients will be enrolled in April 1999, with plans
to continue recruitment until February 2001. Countries currently participating
include the United States, Canada, Argentina, Australia, Austria, Belgium,
Chile, Denmark, France, Germany, Israel, Italy, Mexico, Netherlands, New
Zealand, Spain, South Africa, Sweden, and the United Kingdom.
Inclusion Criteria:
- Age greater than or equal to 65 years if the patient is eligible for
reperfusion therapy (thrombolysis or primary angioplasty), or any age if the
patient is not eligible for reperfusion therapy
- Ischemic chest discomfort lasting at least 30 minutes
- EKG revealing 1mm of ST elevation in 2 contiguous limb leads or 2mm of ST
elevation in 2 contiguous precordial leads, or new LBBB
- Able to receive study drug within 6 hours of symptom onset
Exclusion Criteria:
- Age < 65 years if the patient is eligible for reperfusion therapy
- Thrombolytic therapy or primary angioplasty for acute myocardial infarction
within one week
- Systolic blood pressure <90 mmHg despite treatment
- Advanced heart block
- Severe renal impairment
- Current participation in another investigational trial, or previous
participation in MAGIC
Treatment:
Patients are randomized to treatment with magnesium sulfate as a 2g bolus
over 15 minutes followed by a 17g infusion over 24 hours, or an identical
placebo (sugar water). There is an equal chance of being assigned to either
magnesium sulfate or placebo, and neither the patient nor the treating physician
will know which treatment the patient actually received.
MAGIC will continue to recruit
new sites until the end of 1999. If you are interested in becoming a MAGIC site, or if you want more
information, please contact the MAGIC Clinical Trial
Center at:
New England Research Institutes
(Project Director: Susan Hagner)
9
Galen Street
Watertown, MA 02472
Phone: (617) 923-7747 x 660
Fax: (617)
926-7090
E-mail: magichelp@neri.org
The NHLBI Project Office is responsible for the overall direction and
management of the study, monitoring the progress of the study, and providing
organizational and scientific guidance. Dr. Yves Rosenberg, the MAGIC Project Officer, may also be
contacted for further information regarding MAGIC:
National Heart, Lung, and Blood Institute
Clinical Trials Scientific
Research Group
6701 Rockledge Drive, MSC 7936
Bethesda, MD
20892-7936
Phone: (301) 435-0399
Fax: (301) 480-3667
E-mail:
rosenbey@gwgate.nhlbi.nih.gov
What is ACES?
ACES is a nationwide research study involving 4,000
participants from more than 25 university medical centers and research health
care centers.
The purpose of this study is to determine whether the
antibiotic azithromycin decreases the risk of having a heart attack or other
complications related to heart disease in people with blockages in the arteries
that lead to the heart.
Azithromycin is an antibiotic that is used to treat infections with a
bacteria called Chlamydia pneumoniae. Some studies have shown that Chlamydia
pneumoniae infection is present in the plaque, or material blocking the heart
vessel, in many people with heart disease and therefore may be a risk factor for
heart attacks and other complications related to heart disease.
Who Can Participate?
Men and women over the age of 18 who have documented coronary artery disease
or blockage in the arteries that lead to the heart muscle. This would include
people who have had:
- One or more heart attacks
- "Bypass surgery"
- Angioplasty or "balloon
procedure"
- Stent placement
- A cardiac catheterization and been told they
have "significant" blockage in the arteries which supply the
heart
We will ask you questions about your general health, your history of heart
disease, the medications you are taking and whether you are allergic to certain
medications.
What Will This Study Involve?
- If you are eligible and agree to participate, you will
continue to be followed and treated for your heart disease by your personal
doctor.
- In addition, you will be assigned by a chance procedure, like
flipping a coin, to take either azithromycin or placebo (a sugar pill) once a
week for one year and will be followed for about 4 years until September 2003.
The U.S. Food and Drug Administration (FDA) has approved azithromycin for use in
treating many types of infections, including pneumonia and skin infections. This
medicine will be provided at no cost to you.
- Participating in the study involves a commitment to take the
study tablets prescribed and to communicate regularly with your study
coordinator about your medical condition.
- You will be monitored for side effects and any change in your
heart condition.
Why Get Involved?
Your voluntary participation in the ACES program is an opportunity for you to
join a national research effort that could help to identify a treatment for
patients like yourself to prevent heart attacks and prolong life. By working
together to reach this important goal, we hope to provide you with the best care
possible and help others.
How Do I Join ACES?
If you or someone you know think you might qualify for this study, please
call the number listed below corresponding to the ACES site nearest
you.
Clinical Site Locations
| University of Alabama at Birmingham |
Birmingham, AL |
(205) 934-4005 |
| Stanford University |
Stanford, CA |
(650) 725-3841 |
| Hospital of Saint Raphael |
New Haven, CT |
(203) 789-3771 |
| George Washington University |
Washington, DC |
(202) 994-8917 |
| University of Florida |
Gainesville, FL |
(352) 376-1611 ext. 6972 |
| Northwestern University |
Chicago, IL |
(312) 908-9464 |
| University of Maryland |
Baltimore, MD |
(410) 328-5396 |
| St. Louis University |
St. Louis, MO |
(314) 577-6015 |
| Robert Wood Johnson Medical School |
Piscataway, NJ |
(732) 235-6546 |
| Columbia University College of Physicians &
Surgeons |
New York, NY |
(212) 305-6154 |
| Mount Sinai Medical Center |
New York, NY |
(212) 241-4258 |
| University of North Carolina |
Chapel Hill, NC |
(919) 966-5201 |
| Wake Forest University School of Medicine |
Winston-Salem, NC |
(336) 716-2679 |
| The Cleveland Clinic Foundation |
Cleveland, OH |
(216) 445-6820 or
445-6823 |
| Hahnemann University |
Philadelphia, PA |
(215) 762-8763 |
| University of Tennessee |
Memphis, TN |
1-800-916-2606 or
(901) 448-8400 |
| Latter Day Saints Hospital |
Salt Lake City, UT |
(801) 408-1863 |
| University of Washington |
Seattle, WA |
(206) 731-4385 |
How Do I Get More Information?
Additional information can be obtained from the ACES Project Director, Dr.
Marcy Winget at (206) 577-0250. Additionally, you may contact either Eleanor
Schron or Debra Egan, ACES Project Officers at:
National Heart, Lung, and Blood Institute
Two Rockledge Center
6701
Rockledge Drive Bethesda, Maryland 20892-7936
Phone: 301-435-0399
Fax:
301-480-3667
Email: schrone@nih.gov egand@nih.gov
Sudden Cardiac Death in Heart Failure Trial
Congestive heart failure (CHF) is a common and lethal disease. A new
diagnosis of CHF is made in over 400,000 North Americans each year. Those with
moderate left ventricular dysfunction have a death rate of 25% over 2 1/2 years,
with 50% of those deaths thought to be due to arrhythmias. The central
hypothesis of this study is that amiodarone or an implantable
cardioverter-defibrillator (ICD) will improve survival compared to placebo in
patients with NYHA Class II and Class III CHF and reduced left ventricular
ejection fraction <35%. This study is sponsored by the NHLBI, Medtronic, Inc., and
Wyeth-Ayerst Laboratories.
The study will be a prospective, clinical trial with 2,500 patients randomly
allocated in equal proportions to three different treatment arms over 2 1/2
years. The first arm of the study will consist of conventional heart failure
therapy and placebo. The second arm of the study will combine conventional
therapy with amiodarone. The third arm of the study will employ conventional
therapy with a pectoral ICD. Treatment arms will be compared using an
intention-to-treat analysis.
The trial will be performed at over 100 North American Institutions. The
Clinical Coordinating Center is at the University of Washington in Seattle,
Washington. The Data Coordinating Center and the Economics and Quality of Life
Coordinating Center are at Duke University in Durham, North Carolina. The ICD
Memory Log Core Laboratory, located at the University of Washington, is a
subunit of the Clinical Coordinating Center focusing on ICD memory analysis.
ENRICHD is a multi-center, randomized controlled clinical trial sponsored by
the National Heart, Lung, and Blood Institute (NHLBI). The trial seeks to
evaluate the effect of a psychosocial intervention in comparison to usual care
on the rates of mortality and re-infarction among patients with documented
myocardial infarction (MI) who are depressed and/or have low social support.
Recruitment began in October, 1996 and will continue until 1999. Recruitment
goals include a total sample size of 3000 patients with 50% minority and 50%
women patients. Patients will be recruited in eight regions around the country
from more than 50 affiliated hospitals.
ENRICHD study candidates are those who meet both of the following
inclusion criteria:
1. Hospitalized for new MI (enzyme-documented MI; < 28 days post-MI)
2.
High psychosocial risk (depressed and/or low social support)
Major Exclusions:
1. Post-procedure MI (CABG or PTCA)
2. Presence of
non-cardiovascular conditions likely to be fatal within one year
3. Major
psychiatric co-morbidity (schizophrenia, dementia, active substance abuse)
More information may be obtained from:
ENRICHD Clinical Coordinating Center
University of North
Carolina
137 East Franklin Street, Suite 203
Chapel Hill, NC
27514
Phone: (919)-962-3085
E-Mail: JIM_HOSKING@UNC.EDU
ENRICHD Study Chairpersons:
Lisa Berkman, PhD
Chair
Harvard School of Public
Health
LBERKMAN@HSPH.HARVARD.EDU
Allan S. Jaffe, MD
Co-chair
SUNY-Health Sciences Center
(Syracuse)
JAFFEA@VAX.CS.HSCSYR.EDU
The NHLBI Project Office is responsible for the overall direction and
management of the study, monitors the progress of the study and provides
organizational and scientific guidance for the study. Dr. Susan Czajkowski, the
ENRICHD Project Officer, may also be contacted for further information regarding
ENRICHD:
Behavioral Medicine Scientific Research Group
Division of Epidemiology and
Clinical Applications
National Heart, Lung, and Blood Institute
Two
Rockledge Centre, Room 8114
6701 Rockledge Drive, MSC 7936
Bethesda, MD
20892-7936
(301) 435-0406
E-Mail: CZAJKOWS@NIH.GOV
ENRICHD Recruitment Regions:
More information about the trial and participating hospitals may be obtained
from the following principal investigators or cardiologists within specific
regions below:
NORTHEAST
New Haven, CT
Boston, MA
SOUTH/SOUTHEAST
Raleigh/Durham, NC
Birmingham,
AL
Miami, FL
MIDWEST
St. Louis,
MO
Chicago, IL
PACIFIC NORTHWEST
Seattle, WA
WEST COAST
Palo
Alto, CA
