Calcium score: what do the most reliable guidelines recommend? An analysis using the G-TRUST tool.

Since 1980, the American College of Cardiology (ACC) and American Heart Association (AHA) have translated scientific evidence into clinical practice guidelines with recommendations to improve cardiovascular health. These guidelines, which are based on systematic methods to evaluate and classify evidence, provide a foundation for the delivery of quality cardiovascular care. The ACC and AHA sponsor the development and publication of clinical practice guidelines without commercial support, and members volunteer their time to the writing and review efforts. Clinical practice guidelines provide recommendations applicable to patients with or at risk of developing cardiovascular disease (CVD). The focus is on medical practice in the United States, but these guidelines are relevant to patients throughout the world. Although guidelines may be used to inform regulatory or payer decisions, the intent is to improve quality of care and align with patients’ interests. Guidelines are intended to define practices meeting the needs of patients in most, but not all, circumstances, and should not replace clinical judgment. Recommendations for guideline-directed management and therapy, which encompasses clinical evaluation, diagnostic testing, and both pharmacological and procedural treatments, are effective only when followed by both practitioners and patients. Adherence to recommendations can be enhanced by shared decision-making between clinicians and patients, with patient engagement in selecting interventions on the basis of individual values, preferences, and associated conditions and comorbidities. The ACC/AHA Task Force on Clinical Practice Guidelines strives to ensure that the guideline writing committee both contains requisite expertise and is representative of the broader medical community by selecting experts from a broad array of backgrounds, representing different geographic regions, sexes, races, ethnicities, intellectual perspectives/biases, and scopes of clinical practice, and by inviting organizations and professional societies with related interests and expertise to participate as partners or collaborators. The ACC and AHA have rigorous policies and methods to ensure that documents are developed without bias or improper influence. The complete policy on relationships with industry and other entities (RWI) can be found online. Beginning in 2017, numerous modifications to the guidelines have been and continue to be implemented to make guidelines shorter and enhance “user friendliness.” Guidelines are written and presented in a modular knowledge chunk format, in which each chunk includes a table of recommendations, a brief synopsis, recommendation-specific supportive text and, when appropriate, flow diagrams or additional tables. Hyperlinked references are provided for each modular knowledge chunk to facilitate quick access and review. More structured guidelines–including word limits (“targets”) and a web guideline supplement for useful but noncritical tables and figures–are 2 such changes. This Preamble is an abbreviated version, with the detailed version available online. The reader is encouraged to consult the full-text guideline(P-1) for additional guidance and details, since the executive summary contains mainly the recommendations.

Primary prevention of coronary artery disease: let's start with calcium score.

At least 25% of coronary patients have sudden death or nonfatal myocardial infarction without prior symptoms.1 Therefore, the search for coronary patients with subclinical disease who could potentially benefit from intensive primary prevention efforts is critically important. The American Heart Association’s (AHA) Prevention V Conference, “Beyond Secondary Prevention: Identifying the High Risk Patient for Primary Prevention,” addressed ways to identify more patients who are asymptomatic and clinically free of coronary heart disease (CHD) but at sufficiently high risk for a future coronary event to justify more intensive risk reduction efforts.2 In this report, we amplify on key findings and recommendations of the AHA Prevention V conference, highlight new research since the conference, and propose an approach to the use of office-based testing and additional noninvasive procedures in selected patients to better define their coronary event risk. The recommendations are concordant with the recently released approach to risk assessment and management from the third report of the Adult Treatment Panel of the National Cholesterol Education Program (ATP-III).3 Enthusiasm for primary prevention and risk assessment in asymptomatic people has been spurred by recent advances in prevention research. Lipid-lowering trials demonstrated that primary prevention of coronary events is feasible, evidenced by the West of Scotland Coronary Primary Prevention Study (WOSCOPS) trial4 of hypercholesterolemic men and by the Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS) trial5 in average or typical risk men and women with only moderate lipid abnormalities. Aspirin6 or ACE inhibitors7 can also reduce risk in selected asymptomatic, high-risk people. Emerging coronary risk factors have been described including inflammatory, infectious, and thrombotic markers,8 and there has been a steady flow of reports that focus attention on potential new ways of predicting coronary risk.9 In addition, noninvasive tests for subclinical atherosclerotic disease are available …

Nobody can go back and start a new beginning, but anyone can start today and make a new ending. — —Maria Robinson Although the Framingham Risk Score forms the bedrock of coronary heart disease (CHD) risk prediction, it has several limitations that have been well documented.1 The clinician is left to manage a significant proportion of patients who have “low to intermediate” estimated risk but accrue the majority of CHD events because they form the majority (≈65%) of the population. Article p 382 To address these deficiencies in the prediction of risk, several investigators have included other markers of risk such as biomarkers related to inflammation, genotypes, or imaging tests with traditional risk factors to improve CHD risk prediction. These analyses have resulted in the creation of novel risk-prediction schemes such as the Reynolds risk score, which added family history and high-sensitivity C-reactive protein (hs-CRP) to blood pressure, smoking, total and high-density lipoprotein cholesterol, and hemoglobin A1C to predict risk.2 However, whether algorithms have used biomarkers such as hs-CRP, imaging tests such as coronary calcium score or carotid intima-media thickness, or novel genotypes such as the single-nucleotide polymorphism on chromosome 9p21, the improvements in risk prediction have been modest. Other investigators have suggested that anybody who is not at very low risk should get an imaging test to further stratify risk.3 On the other hand, there have been efforts to identify the “lifetime risk” of CHD for individuals in various age groups. The concept of lifetime risk was highlighted in the National Cholesterol Education Program Adult Treatment Panel (ATP) III guidelines4 and is an important one, especially for individuals who are young to middle-aged. Traditional risk factors become manifest more often in the 4th and 5th decades of life when the estimated lifespan based on …

Coronary artery calcium (CAC) scoring by computed tomography (CT) has been the subject of intense interest and critical scrutiny since it was first reported as a clinical tool in 1990.1 With improvements in study design, greater availability of coronary CT scanners, and increased attention to the posttest prognosis of patient samples and asymptomatic individuals who have undergone coronary CT, CAC measurement is now considered a potentially useful test for improving coronary risk assessment in selected intermediate-risk asymptomatic patients in whom high CAC scores signify increased cardiovascular risk beyond that predicted by conventional cardiovascular risk factors alone.2 Article p 1693 At the other end of the spectrum, does a very low CAC score signify very low risk? An American Heart Association writing group3 stated that a CAC score of zero (CAC=0; ie, no calcified plaque detected) indicated 1) that the presence of atherosclerotic plaque, including unstable or vulnerable plaque, was highly unlikely; 2) that the presence of significant luminal obstructive disease was highly unlikely (negative predictive value on the order of 95% to 99%); and 3) that the risk of a cardiovascular event in the next 2 to 5 years was quite low (0.1 per 100 person-years). In addition, at least 1 early study suggested that CAC=0 might be useful in the emergency room setting as a tool to rule out myocardial ischemia in symptomatic patients.4 A recent review article5 suggested the same conclusions. However, as pointed out by a different …

Microalbuminuria

Association of pulse wave velocity with vascular and valvular calcification in hemodialysis patients

British Journal of Clinical PharmacologyVolume 43, Issue 1 p. 3-7 Free Access Fraud and misconduct in medical research Frank Wells, Frank Wells 3 The Granaries, Tuddenham St Martin, Ipswich 1P6 9BW, UKSearch for more papers by this author Frank Wells, Frank Wells 3 The Granaries, Tuddenham St Martin, Ipswich 1P6 9BW, UKSearch for more papers by this author First published: 18 July 2008 https://doi.org/10.1111/j.1365-2125.1997.tb00129.xCitations: 1AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat References 1 Brock P. A pharmaceutical company's approach. In Fraud and Misconduct in Medical Research (ed SP Lock, FO Wells) 1996 London : BMJ Publishing Group. 2 Dyer O. GP struck off for fraud in drug trials. Br Med J 1996; 312: 643. 3 Swan N. Preventing and dealing with scientific fraud in Australia. Med J Aust 1989; 150: 169– 170. 4 Lock SP. Lessons from the Pearce affair: handling scientific fraud. Br Med J 1995; 310: 1547– 1548. 5 Association of the British Pharmaceutical Industry. Report on fraud and misconduct in clinical research. London : ABPI, 1992. 6 Royal College of Physicians of London. Report on fraud and misconduct in medical research. London : RCP, 1991. 7 Editorial. Dealing with deception. Lancet 1996; 347: 843. 8 Association of the British Pharmaceutical Industry. Guidelines for investigators on good clinical (research) practice. London : ABPI, 1996. 9 Association of the British Pharmaceutical Industry. Good Clinical Research Practice Guidelines. London : ABPI, 1988. 10 European Commission. Good Clinical Practice Guidelines. Brussels : EC, 1991. 11 International Conference on Harmonisation: Guidelines on Good Clinical Practices. Geneva : IFPMA, 1996. 12 Association of the British Pharmaceutical Industry. Statistical methods in the investigation of fraud. London : ABPI, 1993. 13 SP Lock, FO. Wells (eds). Fraud and Misconduct in Medical Research. London : BMJ Publishing Group, 1996. Citing Literature Volume43, Issue1January 1997Pages 3-7 ReferencesRelatedInformation

Vascular Protection in People with Diabetes

This scientific statement reviews the scientific data for cardiac computed tomography (CT) related to imaging of coronary artery disease (CAD) and atherosclerosis. Cardiac CT is a CT imaging technique that accounts for cardiac motion, typically through the use of ECG gating. The utility and limitations of generations of cardiac CT systems are reviewed in this statement with emphasis on CT measurement of CAD and coronary artery calcified plaque (CACP) and noncalcified plaque. Successive generations of CT technology have been applied to cardiac imaging beginning in the early 1980s with conventional CT, electron beam CT (EBCT) in 1987, and multidetector CT (MDCT) in 1999. Compared with other imaging modalities, cardiac CT has undergone an accelerated …

Association of Lipoprotein Subfractions and Coronary Artery Calcium In Patient at Intermediate Cardiovascular Risk

1349 Good clinical practice (GCP)

Background:Clinical trials play an important role in the generation of evidence-based data in health care practices. To ensure the credibility of data and the safety and well-being of the patients Good clinical practice (GCP) guidelines play an important role. At present, we have little knowledge about awareness of GCP guidelines among health care providers in India.Aim:To assess the level of awareness, and perception of the health care providers toward GCP and subsequent change in these after a dayer training session on GCP guidelines.Settings and Design:A cross-sectional descriptive questionnaire-based study was conducted amongst health care providers, that is, doctors, dentists, nurses of a Tertiary Health Care and Teaching Institute.Materials and Methods:Participants were given descriptive questionnaire; they completed the questionnaire before and after undergoing a day training program in GCP guidelines.Statistical Analysis Used:The impact of the effectiveness of educational intervention among healthcare professionals was evaluated by two-tailed Z-test.Results:Out of 120 participants, 80 were medical doctors, 20 dental doctors, and 20 nurses. A dayse training program on GCP guidelines was found to increase positive attitudes toward various aspects of clinical trials.Conclusion:A day's training program on GCP guidelines may help to increase the knowledge as well as awareness about principles and techniques of clinical research, which will increase the credibility of clinical research in the country.

Statin Intolerance and Noncompliance: An Empiric Approach

WHO has developed Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products in order to establish globally applicable standards for the conduct of biomedical research on human subjects. A number of countries have no regulations for clinical trials or the regulations require supplementation. In those countries, the relevant health authority may designate, in part or in whole, the WHO GCP Guidelines as the basis on which clinical trials will be conducted. This article discusses the functions, obligations and responsibilities of the investigator as defined in the WHO GCP.