There is only one Cardiolite

Myocardial Perfusion and Function assessed by a Gated Cardiolite® Study

In patients with known or suspected CAD .  .  .
The Signs May Be There.

*Based on a prospective study of 5,807 consecutive patients, designed to determine the incremental prognostic value of SPECT for the prediction of cardiac death and the implications for risk stratification in patients undergoing dual-isotope SPECT with either exercise or pharmacological stress and followed for 642 ± 226 days, with prognostic data available for 5,183 patients.4

†Based on a study of 1,230 consecutive patients undergoing adenosine stress dual-isotope SPECT.  The evaluation of referral patterns to catheterization was based on 1,159 patients, but prognostic data presented here is based on 1,079 patients to (1) determine the incremental prognostic value of adenosine stress SPECT; (2) evaluate the ability of SPECT to successfully risk stratify patients in various clinical risk categories; and (3) assess the actual use of this test by healthcare professionals relative to goals 1 and 2 by examining the rates and predictors of referral to catheterization after adenosine stress.5

Diagnostic and prognostic information may help you optimize your patient management decisions5,6

An MPI with Cardiolite® and gated SPECT combines perfusion and function in a single test1

Perfusion

  • Helps establish:
    • Extent of disease (single vessel vs multivessel)2,4
    • Severity of disease
    • Degree of reversibility
  • Predictor of MI and cardiac death4,5

The greater the perfusion defect, the greater the risk of MI or cardiac death4,5

Function

  • Helps establish:
    • LVEF and LV function2,3
    • Wall motion
    • Wall thickening
  • Predictor of cardiac death3,7

The lower the ejection fraction, the greater the risk of cardiac death3,7

  • Cardiolite® with gated SPECT provides incremental prognostic information over perfusion alone in patients with known or suspected coronary artery disease (CAD)3,7

5-Fold Greater Predictability Over Clinical Testing or Clinical Testing Plus Exercise Treadmill Testing (ETT)6‡§

5-fold incremental prognostic value demonstrated
in 2113 patients with no history of CAD6

‡An MPI with Cardiolite® and gated SPECT6

§Based upon a study of 2,268 consecutive patients undergoing dual-isotope MPI and followed up for 566 ± 142 days, with 2,200 patients available for follow-up; however, the prognostic data was based on a population of 2,113 patients. This study was designed to determine the incremental prognostic value of exercise stress MPI in patients without previously defined CAD, to define the clinical role of the test in risk stratification in this population, and to determine the impact of this test on patient management as measured by post-nuclear testing referral of patients to catheterization and revascularization6

Rely on the Power of Information Available to You

It All Adds Up to Information to Help Make Confident Patient Management Decisions

Click here to view footnotes
  1. Cardiolite® [package insert]. N. Billerica, MA: Lantheus Medical Imaging; 2009.
  2. ASNC Imaging Guidelines for Nuclear Cardiology Procedures: Stress Protocols and tracers
    Tilkemeier et al., Journal of Nuclear Cardiology 2009 Accessed Dec. 2009
    http://anc.org/imageuploads/ImagingGuidelinesStressProtocols021109.pdf
  3. Sharir et al. Prediction of Myocardial Infarction Versus Cardiac Death by Gated Myocardial Perusion SPECT. J Nucl Med. 2001;42:831-37.
  4. Hachamovitch R, Berman DS, Shaw LJ, et al. Incremental prognostic value of myocardial perfusion single photon emission computed tomography for the prediction of cardiac death: differential stratification for risk of cardiac death and myocardial infarction. Circulation. 1998;97:535–543.
  5. Hachamovitch R, Berman DS, Kiat H, et al. Incremental prognostic value of adenosine stress myocardial perfusion single-photon emission computed tomography and impact on subsequent management in patients with or suspected of having myocardial ischemia. Am J Cardiol. 1997;80:426–433.
  6. Hachamovitch R, Berman DS, Kiat H, et al. Exercise myocardial perfusion SPECT in patients without known coronary artery disease: incremental prognostic value and use in risk stratification. Circulation. 1996;93:905–914.
  7. Sharir T, Germano G, Kavanaugh P, et al. Incremental Prognostic Value of Post-Stress Left Ventricular Ejection Fractin and Volume by Gated Myocardial Perfusion SPECT. Circulation. 1999;100:1035-1042.

 

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