scholarly journals Association of Clinical Trial Participation After Myocardial Infarction with Socioeconomic Status, Clinical Characteristics, and Outcomes

2021 ◽  
Author(s):  
Joel Ohm ◽  
Tomas Jernberg ◽  
David Johansson ◽  
Anna Warnqvist ◽  
Margrét Leosdottir ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Clinical Trial ◽  
Socioeconomic Status ◽  
Heart Disease ◽  
Clinical Characteristics ◽  
Left Ventricular ◽  
Trial Participation ◽  
Real World Data ◽  
Individual Level ◽  
Trial Participants

Abstract Aims To investigate whether participants in clinical trials after myocardial infarction (MI) are representable for the post-MI population concerning characteristics, secondary prevention, and prognosis. Methods and Results Cohort study on 31,792 attendants to 1-year revisits after MI throughout Sweden (n = 2941 clinical trial participants) between 2008 and 2013 identified in the Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART). Individual-level data on socioeconomic status (SES) (disposable income, educational level, and marital status) and outcomes (first recurrent nonfatal MI, coronary heart disease death, fatal or nonfatal stroke until study end 2018) were linked from other national registries. Trial participants were more likely to be men (risk ratio 1.09; 95% confidence interval 1.07-1.11), to be married (1.07; 1.04-1.10), have a highest-quintile income (1.42; 1.36-1.48), and post-secondary education (1.25; 1.18-1.33) while less likely to have a history of MI (0.88; 0.80-0.97), be persistent smokers (0.83; 0.75-0.92) and have left ventricular dysfunction (0.59; 0.44-0.79) compared to non-participants. During a mean 6.7-year follow-up, 5,206 outcome events occurred. Risk was lower in trial participants (hazard ratio 0.80; 95% CI 0.72-0.89), also after adjusting for clinical characteristics and post-MI therapies (0.85; 0.77-0.94) and additionally for SES (0.88; 0.79-0.97). Conclusions Clinical trial participants post-MI are more often male, have higher SES, a more advantageous risk profile, and better prognosis. Additional unmeasured participation bias was implied. Questionable external validity of post-MI trials highlights the importance of complementary studies using real-world data.

Overall survival of men with metastatic castration-resistant prostate cancer (mCRPC) receiving first-line docetaxel-containing chemotherapy according to their participation (or not) in clinical trials.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 148-148
Author(s):  
Jatinder Goyal ◽  
Peng Huang ◽  
Prachi Tyagi ◽  
Daniel Oh ◽  
Michael Anthony Carducci ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Clinical Trials ◽  
Clinical Characteristics ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
First Line ◽  
Trial Participants ◽  
Baseline Hemoglobin

148 Background: There is insufficient evidence to determine whether clinical trial participation can itself lead to improved clinical outcomes in patients with mCRPC treated with docetaxel chemotherapy. We compared clinical characteristics and survival outcomes of patients with mCRPC receiving first-line docetaxel-containing therapy on a clinical study (trial participants) or outside of a clinical trial (non-participants). Methods: We retrospectively reviewed the records of 245 consecutive chemotherapy-naïve patients with mCRPC who received docetaxel-containing therapy between 1/1/1998 and 1/1/2010, either as trial participants (n=142; 11 separate studies) or as non-participants (n=103). Patient demographics, baseline clinical characteristics, treatment details and follow-up data were recorded. Results: In unadjusted analysis, trial participants were more likely to be white (83 vs 70%, p=0.005), to have better ECOG performance status (p=0.01), higher baseline hemoglobin (12.4 vs 11.6 g/dL, p=0.0003), higher albumin (4.3 vs 4.0 g/dL, p=0.009), lower creatinine (0.90 vs 1.04 mg/dL, p=0.01), and to have received a higher number of chemotherapy cycles (6.6 vs 5.1, p=0.001) than non-participants. In Kaplan-Meier analysis, median overall survival was significantly longer among trial participants vs non-participants (21.3 vs 17.1 months, p=0.024). In multivariable analysis, trial participation (HR 0.53, p=0.013), more chemotherapy cycles (HR 0.87; p=0.0002), baseline hemoglobin >12 g/dL (HR 0.67, p=0.016), lower ECOG score (HR 0.57, p=0.026) and lower baseline (log) PSA (HR 0.85, p=0.012) were all found to be independent predictors of survival. Conclusions: Clinical trial participation is an independent positive predictor of overall survival in men undergoing first-line docetaxel-containing chemotherapy for mCRPC. Improved survival in trial participants may reflect better medical oversight typically seen in patients enrolled in clinical trials, more regimented follow-up schedules, or a positive effect on caregivers’ attitudes due to greater contact with medical services.

Abstract MP52: Sex Differences In The Association Between Neighborhood Social Vulnerability And Psychological Distress Among Patients With Heart Disease

Circulation ◽  
2021 ◽  
Vol 143 (Suppl_1) ◽  
Author(s):  
Samaah Sullivan ◽  
An Young ◽  
Mariana Garcia ◽  
Zakaria Almuwaqqat ◽  
Kasra Moazzami ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Socioeconomic Status ◽  
Heart Disease ◽  
Psychological Distress ◽  
Social Factors ◽  
Social Vulnerability ◽  
Census Tracts ◽  
Individual Level ◽  
Unit Increase ◽  
Percentile Ranking

Introduction: Psychological stress disorders are twice as prevalent in women with ischemic heart disease compared to their male counterparts. The disproportionate psychological health experience of these women is not well understood. Neighborhood social factors may help to explain disparities in psychological risk by sex. Hypothesis: We hypothesized that in patients with a recent myocardial infarction, living in neighborhoods with higher social vulnerability would be associated with greater psychological distress. We also hypothesized that this association would be moderated by sex, with a greater association among women than men. Methods: We studied 286 patients with heart disease recruited from Emory-based hospitals in the Myocardial Infarction and Mental Stress 2 Study. We used the social vulnerability index (SVI) developed by the Centers for Disease Control and Prevention to rank patients’ census tracks on 14 social factors, including unemployment, lack of vehicle access, and crowded housing, which are further grouped into four themes: socioeconomic status; household composition; minority status and language; and housing and transportation. Census tracts received a percentile ranking (0-100%), overall and for each theme, with higher values indicating greater social vulnerability. We calculated a global measure of psychological distress by ranking each participant on each of six symptom scales (depression, post-traumatic stress disorder, anxiety, anger, hostility, and perceived stress) and then taking an average of all ranks. Multilevel linear regression models were used to account for individuals nested within census tracts. Beta coefficients for mean ranks in psychological distress scores were estimated per 10-unit increase in SVI percentile ranking. Results: The mean age of the sample was 51 years (range: 26-61); 49% were women and 66% African American. Women in higher SVI census tracts had greater psychological distress scores. After adjusting for demographics (age, race, individual-level education and income), lifestyle and medical risk factors, and anti-depressant use, there were significant differences by sex (SVI-by-sex-interaction = 0.01) such that each 10 unit increase in SVI percentile ranking was associated with 4.09 (95% CI: 0.02, 8.08; p = 0.05) unit increase in mean scores for psychological distress among women only. These associations were driven by the SVI themes of lower socioeconomic status and poorer access to housing and transportation. There were no significant interactions by race. Conclusions: We show for the first time that neighborhood social vulnerability is associated with psychological distress among women with heart disease. These findings support the role of contextual influences of the neighborhood environment on the mental health of high-risk women, independent of individual-level measures of income and education.

scholarly journals Effect of cardiosphere-derived cells on segmental myocardial function after myocardial infarction: ALLSTAR randomised clinical trial

Open Heart ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e001614
Author(s):  
Mohammad R Ostovaneh ◽  
Raj R Makkar ◽  
Bharath Ambale-Venkatesh ◽  
Deborah Ascheim ◽  
Tarun Chakravarty ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Clinical Trial ◽  
Myocardial Function ◽  
Randomised Clinical Trial ◽  
Scar Tissue ◽  
Left Ventricular ◽  
Lv Function ◽  
Cardiac Events ◽  
Lv Dysfunction ◽  
Registration Number

BackgroundMost cell therapy trials failed to show an improvement in global left ventricular (LV) function measures after myocardial infarction (MI). Myocardial segments are heterogeneously impacted by MI. Global LV function indices are not able to detect the small treatment effects on segmental myocardial function which may have prognostic implications for cardiac events. We aimed to test the efficacy of allogeneic cardiosphere-derived cells (CDCs) for improving regional myocardial function and contractility.MethodsIn this exploratory analysis of a randomised clinical trial, 142 patients with post-MI with LVEF <45% and 15% or greater LV scar size were randomised in 2:1 ratio to receive intracoronary infusion of allogenic CDCs or placebo, respectively. Change in segmental myocardial circumferential strain (Ecc) by MRI from baseline to 6 months was compared between CDCs and placebo groups.ResultsIn total, 124 patients completed the 6-month follow-up (mean (SD) age 54.3 (10.8) and 108 (87.1%) men). Segmental Ecc improvement was significantly greater in patients receiving CDC (−0.5% (4.0)) compared with placebo (0.2% (3.7), p=0.05). The greatest benefit for improvement in segmental Ecc was observed in segments containing scar tissue (change in segmental Ecc of −0.7% (3.5) in patients receiving CDC vs 0.04% (3.7) in the placebo group, p=0.04).ConclusionsIn patients with post-MI LV dysfunction, CDC administration resulted in improved segmental myocardial function. Our findings highlight the importance of segmental myocardial function indices as an endpoint in future clinical trials of patients with post-MI.Trial registration numberNCT01458405.

Chronic ischaemic heart disease

2018 ◽  
pp. 179-201
Author(s):  
Bernhard L Gerber ◽  
Mouaz H Al-Mallah ◽  
Joao AC Lima ◽  
Mohammad R Ostovaneh
Keyword(s):  
Myocardial Infarction ◽  
Heart Disease ◽  
Magnetic Resonance ◽  
Ischaemic Heart Disease ◽  
Myocardial Ischaemia ◽  
Dobutamine Stress ◽  
Left Ventricular ◽  
Contractile Reserve ◽  
Additional Information ◽  
Artery Disease

Chronic ischaemic heart disease (IHD) is one of the most common cardiac conditions worldwide and is generally caused by the consequences of coronary atherosclerosis, including myocardial infarction. Clinical challenges in chronic IHD include detection of myocardial ischaemia in symptomatic patients with suspected coronary artery disease (CAD), evaluation of myocardial viability in patients with established IHD and poor left ventricular ejection fraction (LVEF) when revascularization is considered, as well as risk stratification and identification of patients with chronic IHD at high risk of complications. Cardiovascular magnetic resonance (CMR) can provide vital answers to all three of these challenges. Stress CMR is now increasingly used to detect ischaemia by means of vasodilator stress perfusion or dobutamine stress contractile reserve stress imaging. For viability assessment, late gadolinium enhancement is currently the method of choice to detect myocardial infarction, and low-dose dobutamine stress magnetic resonance can provide additional information to determine viability and guide therapy. Cardiovascular risk in patients with chronic IHD is mainly determined by left ventricular function, most commonly utilizing LVEF, as well as infarct size, infarct characteristics, and ischaemic burden, which can all be measured reliably with CMR. This chapter will review the role of CMR for the detection of myocardial ischaemia, viability, and risk.

Participation in a research study related to acute myocardial infarction is not a guarantee to live more longer: results from the FAST-MI registries

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Puymirat ◽  
F Schiele ◽  
F Roubille ◽  
V Tea ◽  
J Ferrieres ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Clinical Trial ◽  
Clinical Outcome ◽  
Clinical Characteristics ◽  
Research Study ◽  
St Elevation Myocardial Infarction ◽  
Lower Mortality ◽  
St Elevation ◽  
One Year

Abstract Background The main potential benefits of participating in a clinical trial is to have access to a treatment that is not available yet and to have a regular and careful attention from physicians. Several data have suggested that inclusion in a research study was associated with better clinical outcome. Aims The aim of this study is to describe the prevalence of inclusions in a research study (i.e., device or medication), clinical characteristics, management and clinical outcome in patients admitted for acute myocardial infarction (AMI) according to participation in a research study (versus not) using data from the French registries of Acute ST-or non-ST-elevation Myocardial infarction (FAST-MI) 2010 and 2015. Methods We used data from 2 one-month French registries, conducted 5 years apart, including 9,414 AMI admitted to coronary or intensive care units. We analyzed baseline characteristics, management and one-year survival according to participation in a research study. Results From 2010 to 2015, the prevalence of patients included in a research study decreased from 6.8% to 3.6% (P&lt;0.001). Inclusions were performed mainly in university hospitals (8%). Clinical characteristics according to participation in a research study were strongly different. Overall, patients included in a research study were younger (61.2±12.7 vs 65.7±14.1; P&lt;0.001) with less previous medical history and co-morbidities. Clinical presentation was preferentially a ST-elevation myocardial infarction (STEMI: 70% vs 52%; P&lt;0.001) in these patients who had a lower GRACE score (133±32 vs. 141±35; P&lt;0.001). The use of invasive strategies was more used in patients included in a research study (coronary angiogram: 99% vs 95%, P&lt;0.001) as prescriptions of recommended medications (i.e., antiplatelet agents, beta-blockers, angiotensin-converting-enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB) and statins) at discharge (72% vs 63%; P&lt;0.001). In a cox multivariate analysis, participation in a research study was not associated with lower mortality at one-year (HR= 0.68, 95% CI, 0.39–1.18, P=0.17). Similar results were observed in patients discharge alive (HR= 0.81, 95% CI, 0.44–1.48, P=0.49). Recommended medications were however more used in patients included in a clinical trial (OR=1.34; 95% CI, 1.09–1.65; P=0.007). Conclusions The number of inclusions in a research study related to AMI in France is low. Our data suggest that patients included in a research study are selected and received more recommended medications and invasive strategies. However, this management is not associated with a lower mortality at one-year. Funding Acknowledgement Type of funding source: None

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