There is only one Cardiolite

Understanding Heart Disease
Risk Factors for Heart Disease

Understanding Heart Disease and
Coronary Artery Disease (CAD)

Heart disease is a term used to describe all the diseases of the heart and blood vessels that feed the heart in the body. Coronary artery disease, or CAD, is the disease of the vessels that supply blood to the heart muscle. It is the most common form of heart disease. CAD is the leading cause of death in the U.S. for both men and women.1 If CAD goes undetected or untreated, there is the potential for more serious complications to occur, such as chest pain (called angina when caused by CAD) or heart attack. Fortunately, there are some important risk factors that can alert your doctor that you may be at risk for heart disease.1,2

Risk Factors:

  • Family history of heart disease
  • Being overweight
  • Lack of exercise
  • Smoking
  • Poor diet and excessive intake of alcohol
  • Diabetes
  • Presence of certain conditions (i.e., high blood pressure [hypertension], high cholesterol [hypercholesterolemia])
  • Postmenopausal status in women
  • Age and gender

Risk factors may assist your doctor in determining your likelihood of having or developing CAD. Unfortunately, they may not provide a complete and accurate answer. Your doctor may want additional information before deciding how to treat you. Myocardial perfusion imaging is often used to determine the presence and severity of physiologically significant CAD.3

Diabetes and Coronary Artery Disease (CAD)

If you have diabetes, here are a few things you should know about your risk for coronary artery disease (CAD), the most common form of heart disease.

Heart disease occurs more often in patients with diabetes as in those without diabetes.4 Commonly silent, heart disease often first manifests itself as acute myocardial infarction or cardiac death.

Risk Factors:

  • Sedentary lifestyle
  • Undesirable cholesterol levels
  • Smoking
  • Family history of premature coronary artery disease
  • High blood pressure

Ask your doctor if a test for heart disease is right for you. The right test will be important to determine whether or not you have CAD.

Women and Coronary Artery Disease (CAD)

According to the U.S. Department of Health and Human Services, one in every four women dies of heart disease.5

Effective diagnosis of CAD in women requires healthcare professionals to understand and recognize the subtle, and often less common symptoms of cardiac ischemia – the condition that occurs when oxygen and bloodflow are cut off from the heart muscle. Some symptoms more commonly found in women may include: abdominal discomfort, nausea or vomiting, shortness of breath or a general feeling of illness (malaise). Women are also more likely to have other less common side effects such as heartburn, loss of appetite, feeling tired, coughing or heart flutters.5

Depending on different factors, your doctor may recommend one or more tests to diagnose CAD. For women, test results can be affected by exercise capacity, body size and breast tissue. In a clinical study, test results were more specific when women received Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection) as part of their screening test.6

Ask your doctor if a test for heart disease is right for you. The right test will be important to determine whether or not you have CAD.

Click here to view footnotes
  1. National Institutes of Health, National Heart, Lung, and Blood Institute. Coronary Artery Disease: Who Is At Risk. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD_all.html. Accessed June 24, 2010.
  2. American Heart Association. Risk factors and coronary heart disease. Available at: http://www.americanheart.org/presenter.jhtml?identifier=4726. Accessed June 24, 2010.
  3. American College of Radiology and Society of Nuclear Medicine Collaborative Guidelines- Practice Guideline for the performance of Cardiac Scintigraphy. Revised 2009. Available at: http://www.acr.org. Accessed June 24, 2010.
  4. American Society of Nuclear Cardioloy - Manage Your Practice - Patient Awareness Brochures Available at: http://www.asnc.org/section_50.cfm. Accessed June 25, 2010.
  5. WomenHealth.gov – Frequently Asked Questions, Heart Disease. Available at http://www.womenshealth.gov/faq/heart-disease.cfm. Accessed June 24, 2010..
  6. Taillefer, R et al., Comparative Diagnostic Accuracy of T1-201 and Tc-99m Sestamibi SPECT Imaging (Perfusion and ECG-Gated SPECT) in Detecting Coronary Artery Disease in Women. J Am Coll Cardiol 1997;29:69-77.

 

Lantheus Medical Imaging

Indications and Usage for Cardiolite®:
Myocardial Imaging:  CARDIOLITE® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions.  CARDIOLITE® evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g. exercise or pharmacologic stress in accordance with the pharmacologic stress agent’s labeling).

CONTRAINDICATIONS:
None known.

IMPORTANT SAFETY INFORMATION: 

CARDIOLITE® has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria.  In some patients the allergic symptoms developed on the second injection during CARDIOLITE® imaging.  The most frequently reported adverse events include headache, chest pain/angina, ST segment changes on ECG, nausea, and abnormal taste and smell.

Infrequently, death has occurred 4 to 24 hours after Tc99m Sestamibi use and is usually associated with exercise stress testing (See Section 5.2). Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events.

WARNINGS AND PRECAUTIONS:
In studying patients in whom cardiac disease is known or suspected, care should
be taken to assure continuous monitoring and treatment in accordance with safe,
accepted clinical procedure.

Caution should be exercised and emergency equipment should be available when administering CARDIOLITE®.

Before administering CARDIOLITE® patients should be asked about the possibility of allergic reactions to either CARDIOLITE® or MIRALUMA®.
MIRALUMA® is an identical compound used in breast imaging.

The contents of the vial are intended only for use in the preparation of Technetium Tc99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure.

Please see full Prescribing Information: Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection)

Indications and Usage for Thallous Chloride Tl 201 Injection:
Thallous Chloride TI 201 Injection may be useful in myocardial perfusion imaging using either planar or SPECT (Single Photon Computed Tomography) techniques for the diagnosis and localization of myocardial infarction.  It may also have prognostic value regarding survival, when used in the clinically stable patient following the onset of symptoms of an acute myocardial infarction, to assess the site and size of the perfusion defect.

Thallous Chloride TI 201 Injection may also be useful in conjunction with exercise stress testing as an adjunct in the diagnosis of ischemic heart disease (atherosclerotic coronary artery disease).

It is usually not possible to differentiate recent from old myocardial infarction, or to differentiate between recent myocardial infarction and ischemia.

Thallous Chloride TI 201 is indicated also for the localization of sites of parathyroid hyperactivity in patients with elevated serum calcium and parathyroid hormone levels.  It may also be useful in pre-operative screening to localize extrathyroidal and mediastinal sites of parathyroid hyperactivity and for postsurgical reexamination.  Thallous Chloride Tl 201 Injection has not been adequately demonstrated to be effective for the localization of normal parathyroid glands.

CONTRAINDICATIONS: None known.

Important Safety Information:
 Following the administration of Thallous Chloride Tl 201  Injection, adverse anaphylactoid reactions have been reported (characterized by cardiovascular, respiratory, and cutaneous symptoms), some severe enough to require treatment.  Hypotension, pruritus, flushing and diffuse rash which responds to antihistamines have been reported.  Other reported events include itching, nausea/vomiting, mild diarrhea, tremor, shortness of breath, chills, fever, conjunctivitis, sweating and blurred vision.

WARNINGS:
In studying patients in whom myocardial infarction or ischemia is known or suspected, care should be taken to assure continuous clinical monitoring and treatment in accordance with safe, accepted procedure.  Exercise stress testing should be performed only under the supervision of a qualified physician and in a laboratory equipped with appropriate resuscitation equipment.
The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex.

PRECAUTIONS:
Data are not available concerning the effect of marked alterations in blood glucose, insulin, or pH (such as is found in diabetes mellitus) on the quality of Thallous ­Chloride TI 201 Injection scans.  Attention is directed to the fact that thallium is a potassium analog, and since the transport of potassium is affected by these factors, the possibility exists that the thallium may likewise be affected.

General

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Thallous Chloride TI 201 Injection, as all radioactive materials, must be handled with care and used with appropriate safety measures to minimize external radiation exposure to patients and to clinical personnel. 

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides.

Please see full Prescribing Information: Thallous Chloride Tl 201 Injection