scholarly journals The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation, and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial.

2021 ◽  
Author(s):  
Ana I Fernandez ◽  
Javier Bermejo ◽  
Raquel Yotti ◽  
Miguel Ángel Martínez-Gonzalez ◽  
Alex Mira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Acute Coronary Syndrome ◽  
Mediterranean Diet ◽  
Atherosclerotic Plaque ◽  
High Intensity ◽  
Plaque Vulnerability ◽  
Diet Intervention ◽  
Coronary Syndrome ◽  
Randomized Controlled ◽  
The Impact

Abstract Background: Primary prevention trials have demonstrated that the traditional Mediterranean diet is associated with a reduction in cardiovascular mortality and morbidity. However, this benefit has not been proven for secondary prevention after an acute coronary syndrome (ACS). We hypothesized that a high-intensity Mediterranean diet intervention after an ACS decreases the vulnerability of atherosclerotic plaques by complex interactions between anti-inflammatory effects, microbiota changes and modulation of gene expression. Methods: The MEDIMACS project is an academically funded, prospective, randomized, controlled and mechanistic clinical trial designed to address the effects of an active randomized intervention with the Mediterranean diet on atherosclerotic plaque vulnerability, coronary endothelial dysfunction, and other mechanistic endpoints. One hundred patients with ACS are randomized 1:1 to a monitored high-intensity Mediterranean diet intervention or to standard-of-care arm. Adherence to diet is assessed in both arms using food frequency questionnaires and biomarkers of compliance. The primary endpoint is the change (from baseline to 12 months) in the thickness of the fibrous cap of a non-significant atherosclerotic plaque in a non-culprit vessel, as assessed by repeated optical-coherence-tomography intracoronary imaging. Indices of coronary vascular physiology and changes in gastrointestinal microbiota, immunological status, and protein and metabolite profiles will be evaluated as secondary endpoints. Discussion: The results of this trial will address the key effects of dietary habits on atherosclerotic risk and will provide initial data on the complex interplay of immunological, microbiome-, proteome- and metabolome-related mechanisms by which non-pharmacological factors may impact the progression of coronary atherosclerosis after an ACS.Trial registration: ClinicalTrials.gov, NCT03842319. Registered on 13 May 2019. https://clinicaltrials.gov/ct2/show/NCT03842319

scholarly journals The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ana I. Fernández ◽  
Javier Bermejo ◽  
Raquel Yotti ◽  
Miguel Ángel Martínez-Gonzalez ◽  
Alex Mira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Acute Coronary Syndrome ◽  
Mediterranean Diet ◽  
Atherosclerotic Plaque ◽  
High Intensity ◽  
Plaque Vulnerability ◽  
Diet Intervention ◽  
Coronary Syndrome ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Primary prevention trials have demonstrated that the traditional Mediterranean diet is associated with a reduction in cardiovascular mortality and morbidity. However, this benefit has not been proven for secondary prevention after an acute coronary syndrome (ACS). We hypothesized that a high-intensity Mediterranean diet intervention after an ACS decreases the vulnerability of atherosclerotic plaques by complex interactions between anti-inflammatory effects, microbiota changes and modulation of gene expression. Methods The MEDIMACS project is an academically funded, prospective, randomized, controlled and mechanistic clinical trial designed to address the effects of an active randomized intervention with the Mediterranean diet on atherosclerotic plaque vulnerability, coronary endothelial dysfunction and other mechanistic endpoints. One hundred patients with ACS are randomized 1:1 to a monitored high-intensity Mediterranean diet intervention or to a standard-of-care arm. Adherence to diet is assessed in both arms using food frequency questionnaires and biomarkers of compliance. The primary endpoint is the change (from baseline to 12 months) in the thickness of the fibrous cap of a non-significant atherosclerotic plaque in a non-culprit vessel, as assessed by repeated optical coherence tomography intracoronary imaging. Indices of coronary vascular physiology and changes in gastrointestinal microbiota, immunological status and protein and metabolite profiles will be evaluated as secondary endpoints. Discussion The results of this trial will address the key effects of dietary habits on atherosclerotic risk and will provide initial data on the complex interplay of immunological, microbiome-, proteome- and metabolome-related mechanisms by which non-pharmacological factors may impact the progression of coronary atherosclerosis after an ACS. Trial registration ClinicalTrials.govNCT03842319. Registered on 13 May 2019

scholarly journals Impact of an online cardiac rehabilitation program after an acute coronary syndrome during SARS-CoV-2 pandemic

2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
A Severo Sanchez ◽  
B Rivero Santana ◽  
E Arbas Redondo ◽  
VM Juarez Olmos ◽  
D Poveda Pinedo ◽  
...  
Keyword(s):  
Health Care ◽  
Acute Coronary Syndrome ◽  
Cardiac Rehabilitation ◽  
Mediterranean Diet ◽  
Cardiovascular Health ◽  
New Technologies ◽  
Rehabilitation Program ◽  
Prevention Measures ◽  
Coronary Syndrome ◽  
The Impact

Abstract Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): Hospital Universitario La Paz Introduction The SARS-CoV-2 pandemic has overloaded health care systems at several fields. Spanish COVID-19 first wave led to the interruption of most cardiac rehabilitation (CRH) programs in our country. Resume activity without compromising patient"s safety has been a challenge. At our centre (a third-level hospital), we modified our routine clinical practice from face-to-face interviews to a complete online CRH program since July 1st 2020. Purpose The aim of this study is to analyse the impact of an online CRH program after hospital discharge for an acute coronary syndrome in health goals and adherence to secondary prevention measures at the end of the program. Methods This is a retrospective study made up of patients who, after suffering an acute myocardial infarction, followed an online CRH program from June to November 2020. A first online assessment is made by a cardiology consultant. Then, it is followed by ten online group interviews of up to three patients and a health care proffesional: either a nurse or a physiotherapist. These interviews last around ninety minutes. Four weeks after, an online follow-up interview is made by a cardiology consultant. These interviews focus either on physical exercise instructions (aerobical exercise and endurance exercise) or educational interviews (ischemic cardiomyopathy, Mediterranean diet, pharmacological treatment, sexual dysfunction, stress management techniques and solution of questions). Results Up to eighty-four patients were included in our CRH program (this means 83% of patients discharged from our hospital after an acute coronary event). Median of time from discharge to first online interview was 8"79 days and from this last one to program beginning, 3"67 days. Four weeks after the beginning of the program, 82% of the patients presented with a LDL-cholesterol level below aim level (< 55 mg/dL). Workout, Mediterranean diet and tobacco abstinence observance rates were over 90%. There were just three patients who gave up or did not complete the program. Conclusion Despite the fact that SARS-CoV-2 pandemic has arisen a huge challenge for ongoing CRH programs in Spain, the benefit that has been showed by them on cardiovascular health, makes it necessary to develop new tools to allow them going on. New technologies are an opportunity for us to keep on following these patients, moreover showing good results as for adherence, availability and patient and operator assesssment.

scholarly journals Is the use of two versus one long-acting bronchodilator by patients with COPD associated with a higher risk of acute coronary syndrome in real-world clinical practice?

2021 ◽  
Vol 8 (1) ◽  
pp. e000840
Author(s):  
Lianne Parkin ◽  
Sheila Williams ◽  
David Barson ◽  
Katrina Sharples ◽  
Simon Horsburgh ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Clinical Practice ◽  
Real World ◽  
Chronic Obstructive ◽  
Treatment Intensification ◽  
Cardiovascular Comorbidity ◽  
Coronary Syndrome ◽  
Long Acting ◽  
The Impact

BackgroundCardiovascular comorbidity is common among patients with chronic obstructive pulmonary disease (COPD) and there is concern that long-acting bronchodilators (long-acting muscarinic antagonists (LAMAs) and long-acting beta2 agonists (LABAs)) may further increase the risk of acute coronary events. Information about the impact of treatment intensification on acute coronary syndrome (ACS) risk in real-world settings is limited. We undertook a nationwide nested case–control study to estimate the risk of ACS in users of both a LAMA and a LABA relative to users of a LAMA.MethodsWe used routinely collected national health and pharmaceutical dispensing data to establish a cohort of patients aged >45 years who initiated long-acting bronchodilator therapy for COPD between 1 February 2006 and 30 December 2013. Fatal and non-fatal ACS events during follow-up were identified using hospital discharge and mortality records. For each case we used risk set sampling to randomly select up to 10 controls, matched by date of birth, sex, date of cohort entry (first LAMA and/or LABA dispensing), and COPD severity.ResultsFrom the cohort (n=83 417), we identified 5399 ACS cases during 281 292 person-years of follow-up. Compared with current use of LAMA therapy, current use of LAMA and LABA dual therapy was associated with a higher risk of ACS (OR 1.28 (95% CI 1.13 to 1.44)). The OR in an analysis restricted to fatal cases was 1.46 (95% CI 1.12 to 1.91).ConclusionIn real-world clinical practice, use of two versus one long-acting bronchodilator by people with COPD is associated with a higher risk of ACS.

scholarly journals Immediate versus staged revascularisation in multivessel coronary disease: an updated meta-analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
F Von Renteln ◽  
S Hassan ◽  
K Szummer ◽  
R Edfors ◽  
D Venetsanos ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Coronary Disease ◽  
Controlled Trial ◽  
Interventional Treatment ◽  
Index Hospitalisation ◽  
Coronary Syndrome ◽  
Coronary Interventions ◽  
Baseline Characteristics ◽  
Meta Regression ◽  
The Impact

Abstract Background Percutaneous coronary interventions (PCIs) are often aimed at the culprit vessel in acute coronary syndromes (ACSs) followed by revascularisation of other stenoses later in the index hospitalisation or shortly after discharge. PCI delay of non-culprit coronary vessels stenoses is supported by lower contrast fluid use and thrombocyte aggregation. Distinct coronary interventions increase the risk of both non- and coronary artery complications, e.g. acute abdominal and periphery artery bleeding, suggesting undertaking all PCIs at the same time. Purpose To assess the effect on mortality and re-myocardial infarction (MI) of immediate versus staged revascularisation in multivessel coronary disease, with the latter constrained to initial PCI of the culprit coronary vessel. Methods The syntax of “randomised controlled trial (RCT) & acute coronary syndrome & complete revascularisation” was undertaken in PubMed. Clinical characteristics were gathered at the index hospitalisation. The intervention scenario was acute coronary syndrome or not. Meta-analyses calculated relative risk (RR) reductions on outcomes of 1) mortality and 2) re-MI. Meta-regression assessed linear difference between interventional treatment benefits and baseline characteristics. Results A total of 148 studies was found. Of those, 8 was found eligible for further analyses and their baseline characteristics are shown in Table 1. Comparison of immediate versus staged revascularisation on mortality was nonsignificant (RR, 1.19; 95% CI: 0.78–1.81, p=0.43) (Figure 1). The impact of Immediate vs staged revascularisation on re-MI was also nonsignificant (RR, 0.83; 95% CI: 0.44–1.55, p=0.56). Meta-regression found no associations between the outcomes and study characteristics (not shown). Conclusion The intervention of immediate compared to staged revascularisation assessed on outcomes of all-cause mortality and re-MI were nonsignificant. Figure 1 Funding Acknowledgement Type of funding source: None

scholarly journals Impact of timing of randomization after an acute coronary syndrome and subsequent events in patients with type 2 diabetes mellitus: an analysis of the EXAMINE trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Elharram ◽  
A Sharma ◽  
W White ◽  
G Bakris ◽  
P Rossignol ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Type 2 Diabetes Mellitus ◽  
Acute Coronary Syndrome ◽  
Primary Outcome ◽  
Funding Source ◽  
Coronary Syndrome ◽  
The Impact

Abstract Background The timing of enrolment following an acute coronary syndrome (ACS) may influence cardiovascular (CV) outcomes and potentially treatment effect in clinical trials. Using a large contemporary trial in patients with type 2 diabetes mellitus (T2DM) post-ACS, we examined the impact of timing of enrolment on subsequent CV outcomes. Methods EXAMINE was a randomized trial of alogliptin versus placebo in 5380 patients with T2DM and a recent ACS. The primary outcome was a composite of CV death, non-fatal myocardial infarction [MI], or non-fatal stroke. The median follow-up was 18 months. In this post hoc analysis, we examined the occurrence of subsequent CV events by timing of enrollment divided by tertiles of time from ACS to randomization: 8–34, 35–56, and 57–141 days. Results Patients randomized early (compared to the latest times) had less comorbidities at baseline including a history of heart failure (HF; 24.7% vs. 33.0%), prior coronary artery bypass graft (9.6% vs. 15.9%), or atrial fibrillation (5.9% vs. 9.4%). Despite the reduced comorbidity burden, the risk of the primary outcome was highest in patients randomized early compared to the latest time (adjusted hazard ratio [aHR] 1.47; 95% CI 1.21–1.74) (Figure 1). Similarly, patients randomized early had an increased risk of recurrent MI (aHR 1.51; 95% CI 1.17–1.96) and HF hospitalization (1.49; 95% CI 1.05–2.10). Conclusion In a contemporary cohort of T2DM with a recent ACS, early randomization following the ACS increases the risk of CV events including recurrent MI and HF hospitalization. This should be taken into account when designing future clinical trials. Figure 1 Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Takeda Pharmaceutical

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