Active Lipid Management In Coronary Artery Disease (ALMICAD) Study

Khanal, Sanjaya; Obeidat, Omar; Hudson, Michael; Al-Mallah, Mouaz; Bloome, Mary; Lü, Mei; Greenbaum, Adam; Kugelmass, Aaron D.; Weaver, W. Douglas

doi:10.1016/j.amjmed.2006.06.048

Cited by 3 publications

(2 citation statements)

References 12 publications

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“…Table 1 shows RCTs with a primary results publication available. Of these 80 RCTs, all but 4 (5%) 26,27,30,78 reported the use of a clinical events classification committee blinded to treatment assignment. These MI definitions are detailed in Supplementary material online, Table S1A-C, and grouping of trials by coronary revascularization rate is provided in Supplementary material online, Table S2.…”

Section: Resultsmentioning

confidence: 99%

Implementation of standardized assessment and reporting of myocardial infarction in contemporary randomized controlled trials: a systematic review

Leonardi

Armstrong

Schulte

et al. 2013

European Heart Journal

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Myocardial infarction (MI) is a key endpoint in randomized controlled trials (RCTs), but heterogeneous definitions limit comparisons across RCTs or meta-analyses. The 2000 European Society of Cardiology/American College of Cardiology MI redefinition and the 2007 universal MI definition consensus documents made recommendations to address this issue. In cardiovascular randomized trials, we evaluated the impact of implementation of three key recommendations from these reports-troponin use to define MI; separate reporting of spontaneous and procedure-related MI; and infarct size reporting. We searched ClinicalTrials.gov and MEDLINE databases for cardiovascular RCTs with more than 500 patients in which enrolment began between September 2000 and July 2012 and that listed MI in the primary endpoint. We searched English-language publications with primary results or design papers. Of 3222 studies screened, 96 (3.0%) met our criteria. We extracted enrolment start date, number of patients and MI events, follow-up duration, and coronary revascularization rate. Data extraction quality was assessed by duplicated extractions. Of 96 RCTs, 80 had a primary results publication, comprising 608 091 patients and 43 621 endpoint MIs. Myocardial infarction represented 45.3% (95% confidence interval, 40.2-50.4) of events in the primary composite endpoint. Troponin defined MI in 57% (53/93) of trials with an MI definition available. Of these RCTs, three used troponin only if creatine kinase-MB was unavailable, six used troponin to define peri-procedural MI, seven specified the 99th percentile as the MI decision limit, and three reported spontaneous and procedure-related MI separately. None reported biomarker-based infarct size, but five reported MI as multiples of the assay upper limit of normal. Although MI is a major component of cardiovascular RCT primary endpoints, standardized MI reporting and implementation of consensus document recommendations for MI definition are limited. Developing appropriate strategies for uniform implementation is required.

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Section: Resultsmentioning

confidence: 99%

Implementation of standardized assessment and reporting of myocardial infarction in contemporary randomized controlled trials: a systematic review

Leonardi

Armstrong

Schulte

et al. 2013

European Heart Journal

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“…However, it is important to develop and prospectively investigate the role of a pharmacist case management program in concert with current standard of care ( i.e ., SPCs) for survivors of stroke/TIA. Because disease management programs do not always work [ 36 , 62 , 63 ], and the benefits (if present) are often condition-specific, such programs must be tested in controlled trials, rather than just assuming they are beneficial. Although ultimately the multifaceted program we are proposing will be judged by its impact on clinical events, this study has been designed to test the impact of our program on important processes of care (medication management and adherence) as well as intermediate outcomes (such as BP and cholesterol levels) that are well-validated as predictors of subsequent stroke and cardiovascular events.…”

Section: Discussionmentioning

confidence: 99%

The preventing recurrent vascular events and neurological worsening through intensive organized case-management (PREVENTION) trial protocol [clinicaltrials.gov identifier: NCT00931788]

et al. 2010

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BackgroundSurvivors of transient ischemic attack (TIA) or stroke are at high risk for recurrent vascular events and aggressive treatment of vascular risk factors can reduce this risk. However, vascular risk factors, especially hypertension and high cholesterol, are not managed optimally even in those patients seen in specialized clinics. This gap between the evidence for secondary prevention of stroke and the clinical reality leads to suboptimal patient outcomes. In this study, we will be testing a pharmacist case manager for delivery of stroke prevention services. We hypothesize this new structure will improve processes of care which in turn should lead to improved outcomes.MethodsWe will conduct a prospective, randomized, controlled open-label with blinded ascertainment of outcomes (PROBE) trial. Treatment allocation will be concealed from the study personnel, and all outcomes will be collected in an independent and blinded manner by observers who have not been involved in the patient's clinical care or trial participation and who are masked to baseline measurements. Patients will be randomized to control or a pharmacist case manager treating vascular risk factors to guideline-recommended target levels. Eligible patients will include all adult patients seen at stroke prevention clinics in Edmonton, Alberta after an ischemic stroke or TIA who have uncontrolled hypertension (defined as systolic blood pressure (BP) > 140 mm Hg) or dyslipidemia (fasting LDL-cholesterol > 2.00 mmol/L) and who are not cognitively impaired or institutionalized. The primary outcome will be the proportion of subjects who attain 'optimal BP and lipid control'(defined as systolic BP < 140 mm Hg and fasting LDL cholesterol < 2.0 mmol/L) at six months compared to baseline; 12-month data will also be collected for analyses of sustainability of any effects. A variety of secondary outcomes related to vascular risk and health-related quality of life will also be collected.ConclusionsNearly one-quarter of those who survive a TIA or minor stroke suffer another vascular event within a year. If our intervention improves the provision of secondary prevention therapies in these patients, the clinical (and financial) implications will be enormous.

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Implementation strategies to improve statin utilization in individuals with hypercholesterolemia: a systematic review and meta-analysis

Jones¹,

Tilberry²,

Gregor³

et al. 2021

Implementation Sci

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Background Numerous implementation strategies to improve utilization of statins in patients with hypercholesterolemia have been utilized, with varying degrees of success. The aim of this systematic review is to determine the state of evidence of implementation strategies on the uptake of statins. Methods and results This systematic review identified and categorized implementation strategies, according to the Expert Recommendations for Implementing Change (ERIC) compilation, used in studies to improve statin use. We searched Ovid MEDLINE, Embase, Scopus, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, and Clinicaltrials.gov from inception to October 2018. All included studies were reported in English and had at least one strategy to promote statin uptake that could be categorized using the ERIC compilation. Data extraction was completed independently, in duplicate, and disagreements were resolved by consensus. We extracted LDL-C (concentration and target achievement), statin prescribing, and statin adherence (percentage and target achievement). A total of 258 strategies were used across 86 trials. The median number of strategies used was 3 (SD 2.2, range 1–13). Implementation strategy descriptions often did not include key defining characteristics: temporality was reported in 59%, dose in 52%, affected outcome in 9%, and justification in 6%. Thirty-one trials reported at least 1 of the 3 outcomes of interest: significantly reduced LDL-C (standardized mean difference [SMD] − 0.17, 95% CI − 0.27 to − 0.07, p = 0.0006; odds ratio [OR] 1.33, 95% CI 1.13 to 1.58, p = 0.0008), increased rates of statin prescribing (OR 2.21, 95% CI 1.60 to 3.06, p < 0.0001), and improved statin adherence (SMD 0.13, 95% CI 0.06 to 0.19; p = 0.0002; OR 1.30, 95% CI 1.04 to 1.63, p = 0.023). The number of implementation strategies used per study positively influenced the efficacy outcomes. Conclusion Although studies demonstrated improved statin prescribing, statin adherence, and reduced LDL-C, no single strategy or group of strategies consistently improved outcomes. Trial registration PROSPERO CRD42018114952.

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Active Lipid Management In Coronary Artery Disease (ALMICAD) Study

Cited by 3 publications

References 12 publications

Implementation of standardized assessment and reporting of myocardial infarction in contemporary randomized controlled trials: a systematic review

Implementation of standardized assessment and reporting of myocardial infarction in contemporary randomized controlled trials: a systematic review

The preventing recurrent vascular events and neurological worsening through intensive organized case-management (PREVENTION) trial protocol [clinicaltrials.gov identifier: NCT00931788]

Implementation strategies to improve statin utilization in individuals with hypercholesterolemia: a systematic review and meta-analysis

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