A Research Method For Detecting Transient Myocardial Ischemia In Patients With Suspected Acute Coronary Syndrome Using Continuous ST-segment Analysis

Each year, an estimated 785,000 Americans will have a new coronary attack, or acute coronary syndrome (ACS). The pathophysiology of ACS involves rupture of an atherosclerotic plaque; hence, treatment is aimed at plaque stabilization in order to prevent cellular death. However, there is considerable debate among clinicians, about which treatment pathway is best: early invasive using percutaneous coronary intervention (PCI/stent) when indicated or a conservative approach (i.e., medication only with PCI/stent if recurrent symptoms occur). There are three types of ACS: ST elevation myocardial infarction (STEMI), non-ST elevation MI (NSTEMI), and unstable angina (UA). Among the three types, NSTEMI/UA is nearly four times as common as STEMI. Treatment decisions for NSTEMI/UA are based largely on symptoms and resting or exercise electrocardiograms (ECG). However, because of the dynamic and unpredictable nature of the atherosclerotic plaque, these methods often under detect myocardial ischemia because symptoms are unreliable, and/or continuous ECG monitoring was not utilized. Continuous 12-lead ECG monitoring, which is both inexpensive and non-invasive, can identify transient episodes of myocardial ischemia, a precursor to MI, even when asymptomatic. However, continuous 12-lead ECG monitoring is not usual hospital practice; rather, only two leads are typically monitored. Information obtained with 12-lead ECG monitoring might provide useful information for deciding the best ACS treatment. Purpose. Therefore, using 12-lead ECG monitoring, the COMPARE Study (electroCardiographic evaluatiOn of ischeMia comParing invAsive to phaRmacological trEatment) was designed to assess the frequency and clinical consequences of transient myocardial ischemia, in patients with NSTEMI/UA treated with either early invasive PCI/stent or those managed conservatively (medications or PCI/stent following recurrent symptoms). The purpose of this manuscript is to describe the methodology used in the COMPARE Study. Method. Permission to proceed with this study was obtained from the Institutional Review Board of the hospital and the university. Research nurses identify hospitalized patients from the emergency department and telemetry unit with suspected ACS. Once consented, a 12-lead ECG Holter monitor is applied, and remains in place during the patient's entire hospital stay. Patients are also maintained on the routine bedside ECG monitoring system per hospital protocol. Off-line ECG analysis is done using sophisticated software and careful human oversight

A research method for detecting transient myocardial ischemia in patients with suspected acute coronary syndrome using continuous ST-segment analysis.

Each year, an estimated 785,000 Americans will have a new coronary attack, or acute coronary syndrome (ACS). The pathophysiology of ACS involves rupture of an atherosclerotic plaque; hence, treatment is aimed at plaque stabilization in order to prevent ce

Effects of an educational intervention on heart failure knowledge, self-care behaviors, and health-related quality of life of patients with heart failure: Exploring the role of depression.

OBJECTIVES:To test effects of an educational intervention on patient-reported outcomes among rural heart failure (HF) patients and to examine whether effects differed between patients with and without depression. METHODS:Patients (N = 614) were randomized to usual care (UC) or 1 of 2 intervention groups. Both intervention groups received face-to-face education, followed by either 2 phone calls (LITE) or biweekly calls until they demonstrated content competency (PLUS). Follow-up lasted 24 months. Statistical analyses included linear mixed models and subgroup analyses by depression status. RESULTS:Both intervention groups showed improvement in HF knowledge at 3 months (LITE-UC, p = 0.003; PLUS-UC, p < 0.001). Improvement lasted 24 months only in the PLUS group. Compared to UC, both intervention groups exhibited better self-care at 3 months (LITE-UC, p < 0.001; PLUS-UC, p < 0.001) and 12 months (LITE-UC, p = 0.001; PLUS-UC, p = 0.002). There were no differences in health-related quality of life (HRQOL) among groups. In subgroup analyses, similar effects were found among non-depressed, but not among depressed patients. CONCLUSION:The educational intervention improved HF knowledge and self-care, but not HRQOL. No intervention effects were observed in patients with depressive symptoms. PRACTICE IMPLICATIONS:The simple educational intervention is promising to improve HF knowledge and self-care. Additional strategies are needed for depressed patients

Predictors of Adherence to Self-Care in Rural Patients With Heart Failure.

BACKGROUND:The common reality of not following a recommended course of treatment is a major cause of poor health outcomes in patients with heart failure (HF). The purpose of this study was to identify predictors of adherence to HF self-care recommendations in rural HF patients who received an intervention to promote symptom management and self-care. METHODS:Data from 349 rural HF patients (42% female, 90% Caucasian) randomized to the intervention arms of the study were used. Adherence was measured using the European Heart Failure Self-Care Scale questionnaire, a brief measure that asks patients to report their adherence to a variety of recommended HF symptom management behaviors (ie, daily weight monitoring, when to call the physician, medications, diet, and exercise). The following predictors were tested: age, gender, marital status, education level, depression score (measured using PHQ-9), anxiety score (measured with the Brief Symptom Inventory), and level of perceived control (measured using Control Attitudes Scale-R). Multivariate linear regression was used to test the model. RESULTS:The model to predict adherence was significant (P < .0001). Of the covariates tested in the regression model, being a male (P = .009), having less anxiety (P = .018), not being depressed (P = .017), and having higher perceived control (P = .003) were predictors of improved self-care score at 3 months. CONCLUSION:Adherence is a multifaceted and a challenging behavior based on the assumption that the patient agrees with self-care recommendations. These data suggest interventions designed to promote adherence behaviors should include an assessment of gender, anxiety, depression, and perceived control for optimal outcomes

Effective strategies for implementing a multicenter international clinical trial

Purpose: International collaboration in research is essential in order to improve worldwide health. The purpose of this paper is to describe strategies used to administer an international multicenter trial to assess the effectiveness of a nursing educational intervention. Design: The study design was a two-group randomized multicenter international clinical trial conducted to determine whether a brief education and counselling intervention delivered by a nurse could reduce prehospital delay in the event of symptoms suggestive of acute coronary syndrome (ACS) in patients previously diagnosed with cardiovascular disease. Method: A flexible but well-defined project structure showed intervention consistency in five sites among three countries and included experienced project coordinators, multidimensional communication methods, strategies to optimize intervention fidelity, site-specific recruitment and retention techniques, centralized data management, and consideration of ethical and budgetary requirements. Findings: Staff at five sites enrolled 3,522 participants from three countries and achieved 80% follow-up obtained at both 12 and 24 months. Conclusion: Multidimensional approaches to maintain consistency across study sites, while allowing flexibility to meet local expectations and needs, contributed to the success of this trial. Clinical Relevance: In order to support appropriate development of an evidence base for practice, nursing interventions should be tested in multiple settings. A range of strategies is described in this paper that proved effective in conducting a multicenter international trial. © 2008 Sigma Theta Tau International