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

 

Cardiolite

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.
  2. Dorbala S, Ananthasubramanium K, Armstrong IS, et al. ASNC Imaging Guidelines: Single photon emission computed tomography (SPECT) myocardial perfusion imaging guidelines: instrumentation, acquisition, processing and interpretation. J Nucl Cardiol. 2018;25:1784-1846.
  3. Sharir T, Germano G, Kang X, et al. Prediction of myocardial infarction versus cardiac death by gated myocardial perfusion SPECT: risk stratification by the amount of stress-induced ischemia and the poststress ejection fraction. J Nucl Med. 2001;42:831-837.
  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 PB, et al. Incremental prognostic value of post-stress left ventricular ejection fraction and volume by gated myocardial perfusion SPECT. Circulation. 1999;100:1035-1042.

 

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)

 

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