SOLICITATION NOTICE
A -- Assessment of the Accuracy of the Troponin Assay
- Notice Date
- 6/30/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- Reference-Number-1019719
- Response Due
- 7/7/2006
- Archive Date
- 7/22/2006
- Description
- This is a combined solicitation for a noncommercial item. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is R1019719 and is issued as a Request for Proposals. The Government plans to award a purcase order for a firm fixed price amount not to exceed $30,000. The Scope of Work follows: Assessment of the Accuracy of the Troponin Assay in the Diagnosis of Myocardial Infarction and How Gender Influences MI Diagnosis and Treatment Introduction We are seeking some clinical data in order to perform an observational study to assess the accuracy of the troponin assay in the diagnosis of myocardial infarction (MI) and how gender influences MI diagnosis and treatment. Background a) Accuracy of Troponin Assays Cardiac troponins are highly sensitive and specific biochemical markers of myocardial cell necrosis and are widely used for the diagnosis of MI.1, 2 Troponin levels rise and fall with MI and with other clinical syndromes associated with infiltrative/inflammatory causes of myocyte death. There are inaccuracies associated with troponin assays as currently used in clinical practice which may result in false-positive and false-negative test results. The results of different troponin assays are not generally comparable. The analytical variability among troponin assays is due to the fact that different troponin assays have wide variations in lower detection limits, upper reference limits, diagnostic cut points, assay imprecision (coefficient of variation),3 and specimen matrices (i.e., serum versus plasma samples). The presence of a large number of manufacturers of troponin assays in the United States market makes standardization difficult. b) Gender Issues Cardiovascular diseases comprise the leading cause of death in both men and women in the United States.4 Gender differences exist among patients with coronary artery disease. The presentation, prognosis, and mortality of the disease are different in men and women. There are disparities in diagnosis and treatment between genders as well. Most of the clinical research regarding the diagnosis and management of coronary heart disease is performed in predominantly male populations. The issue of variation in the diagnosis, treatment, and prognosis of ACS by gender is complex. On the one hand, women presenting with symptoms of ACS tend to have a higher frequency of angiographically normal coronary arteries than men5-10. This may explain why some studies of ACS demonstrate that women tend to have less severe disease and a better prognosis than men11. This in turn may be due to the fact that a greater percentage of women who present with symptoms of cardiac ischemia may have a non-cardiac disease as the basis for those symptoms. On the other hand, most ACS trials show women to have higher morbidity and mortality than men although this difference is usually narrowed or eliminated when outcome is controlled for various confounding variables such as age, diabetes, and heart failure12. If women are really at greater risk for worse outcomes associated with ACS than are men, one explanation for this may be that they tend to be treated less aggressively than men even when more aggressive treatment is warranted. Purpose The primary purpose of this project is: 1) to assess the accuracy and positive and negative predictive values of the troponin assay in the diagnosis of MI, and 2) to assess how the diagnosis and treatment of MI vary by gender. The secondary objective of the study is to assess whether the accuracy and predictive values of troponin assays vary by gender. Data Source Requirements We will conduct an observational study to investigate the stated objectives. The data may be collected retrospectively or prospectively. The study population consists of male and female patients at medical facilities who are evaluated and treated, if indicated, for MI. The source of data may be from a health care facility or a registry. In either case, the data must be in an electronic format for ease of accessibility and data extraction. The data will include the following elements: Demographic data: age, race, and gender Troponin test results Type of troponin assays performed Other clinical data relevant to the diagnosis of MI Admission and discharge diagnoses Coronary artery disease related treatments Other co-morbidities related to the elevation of troponin in the absence of an MI We will need records on at least 31,000 patients with a diagnosis of MI and at least 2,000 to 16,000 patients who are evaluated for MI and are found not to have had an MI. Only patients who have received a troponin test can be included in this study. Firm Fixed Price ? Not to Exceed $30,000 We have received funding from the FDA Office of Women?s Health in the amount of $30,000 which will be solely appropriated for the purchase of the data and the performance of the data analyses. This is the only funding available for this project. Evaluation Criteria 1. An electronic database from a health care facility or a registry 2. The number of records that include clinical data from a population consisting of male and female patients at medical facilities who are evaluated and treated, if indicated, for MI, and with the required data elements. 3. Supplying the raw data to the investigators will be considered very favorably. 4. However, if the data owner does not release the raw data to FDA, it should provide the statistical analyses based on a detailed plan from the investigators including, but not limited to: From the above mentioned data, MI status of each patient will be determined. There will be three categories for MI classification based on the MI definitions: definite, probable, and negative. (We will supply the specific diagnostic criteria for each category.) Age-, race-, and gender-specific calculations will be performed for the sensitivity, specificity, positive predictive value, and negative predictive value of troponin assay in the diagnosis of MI. The effect of gender for the likelihood of receiving a discharge diagnosis of MI and the likelihood of receiving treatment for MI will be assessed. 5. The projected time line for the study is approximately one year. This means that the contractor should demonstrate the capability of either providing the raw data to the FDA within six months of the receipt of funding or completing the final study analyses within eight months of the receipt of funding. 6. Price References Alpert JS, Thygesen K, Antman E, Bassand JP. Myocardial Infarction Redefined - A Consensus Document of The Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction. The Joint European Society of Cardiology/American College of Cardiology Committee. Journal of the American College of Cardiology 2000; 36(3):959-969. 2 Wu AHB, Apple FS, Gibler WB, Jesse RL, Warshaw MM, Valdes R Jr. National Academy of Clinical Biochemistry Standards of Laboratory Practice: Recommendations for the Use of Cardiac Markers in Coronary Artery Diseases. Clinical Chemistry 1999; 45(7):1104-1121. 3 Apple FS. Cardiac Troponin assays Analytical Issues and Clinical Reference Range Cutpoints. Cardiovascular Toxicology 2001; 1:93-98. 4 Writing Group Members, Thom T, et al. Heart Disease and Stroke Statistics?2006 Update. A Report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation Published online Jan. 11, 2006. 5 Hung J, Chaitman B, Lam J, et al. Noninvasive Diagnostic Test Choices for the Evaluation of Coronary Artery Disease in Women: A Multivariate Comparison of Cardiac Fluoroscopy, Exercise electrocardiography and Exercise Thallium Myocardial Perfusion Scintigraphy. Journal of the American College of Cardiology 1984; 4:8-16. 6 Hochman JS, McCabe CH, Stone PH, et al., the TIMI Investigators. Outcome and Profile of Women and Men Presenting with Acute Coronary Syndromes: A Report from Thrombolysis in Myocardial Infarction (TIMI IIIB). Journal of the American College of Cardiology 1997; 30:141-148. 7 Guiteras P, Chaitman B, Waters D, et al. Diagnostic Accuracy of Exercise ECG Lead Systems in Clinical Subsets of Women. Circulation 1982; 65:1465-1474. 8 Scirica BM, Moliterno DJ, Every NR, et al., the GUARANTEE Investigators. Differences between Men and Women in the Management of Unstable Angina Pectoris (the GUARANTEE Registry). American Journal of Cardiology 1999; 84:1145-1150. 9 Sullivan AK. Chest Pain in Women: Clinical, Investigative, and Prognostic Features. British Medical Journal 1994; 308:883-886. 10 Weiner DA, Ryan TJ, McCabe CH, et al. Exercise Stress Testing: Correlations among History of Angina, ST Segment Response and Prevalence of Coronary Artery Disease in the Coronary Artery Surgery Study (CASS). New England Journal of Medicine 1979; 301:230-235. 11 Lagerqvist B, Safstrom K, Stahle E, Wallentin L, Swahn E, the FRISC II Study Group Investigators. Is Early Invasive Treatment of Unstable Coronary Artery Disease Equally Effective for Both Women and Men? Journal of the American College of Cardiology 2001; 38(1):41-48. 12 Bennett SK, Redberg RF. Acute Coronary Syndromes in Women: Is Treatment Different? Should It Be? Current Cardiology Reports 2004; 6:243-252. Proposals shall be submitted electronically to Elizabeth.Osinski@fda.hhs.gov by 07/07/2006. Proposals must be on a fixed price basis. Proposals will be evaluated on the basis of technical and price factors and award will be based on the best value to the government. A more detailed scope of work is available upon request by contacting the contract specialist, Elizabeth Osinski.
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