ProtecT-2-D trial protocol: cardiovascular protection in patients with type 2 diabetes and established heart and/or vascular disease at a cardio-metabolic clinic-a randomized controlled trial.
Cardiovascular disease remains the primary cause of morbidity and mortality despite advancements in the treatment of patients with type 2 diabetes. Effective diabetes management extends beyond blood glucose control and includes cardiovascular prevention and treatment. However, the conventional healthcare model often emphasizes single-disease-specific management, leading to fragmented care. We aim to establish an affordable Cardio-Metabolic Clinic (CMC) that can provide comprehensive assessment and specialized care with a focus on cardiovascular protection.
The ProtecT-2-D study is a prospective, randomized control trial at the Cardiovascular Research Unit, Odense University Hospital Svendborg, Denmark. In this study, 1500 participants with type 2 diabetes and cardiovascular disease will be randomly assigned in a 2:1 ratio to receive either the intervention: treatment in the CMC, or the control: standard of care. The Cardio-Metabolic Clinic applies a decision-making algorithm coded with the latest guidelines to evaluate lifestyle factors and manage medical treatment. Health examinations are conducted at baseline and after three years, and clinical events will be assessed through registry and journal audits after five and ten years. The primary outcome is the time to the first occurrence of a composite of cardiovascular deaths, non-fatal acute myocardial infarctions, non-fatal stroke, or hospitalization due to heart failure at a time frame of five years.
The Cardio-Metabolic Clinic represents a pioneering approach to diabetes management that aims to improve patient outcomes by reducing the cardiovascular disease burden. This study could transform diabetes care and offer a multidisciplinary, cost-effective, and specialized treatment. We need to establish the efficacy and feasibility of a CMC to integrate comparable clinics into broader healthcare systems, and potentially enhance cardiovascular health in patients with type 2 diabetes.
ClinicalTrials.gov NCT06203860.
Overgaard KS
，Mohamed RA
，Andersen TR
，Lambrechtsen J
，Egstrup K
，Auscher S
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《Cardiovascular Diabetology》
Geographic proximity to cardiovascular clinical trial sites: A National analysis in the United States.
Suboptimal geographical access to cardiovascular clinical trial sites (CV-CTS) may be a cause of inadequate demographic representation in contemporary trials. Thus, we investigate access to CV-CTS in the US.
We obtained the location of CV-CTS from Clinicaltrials.gov. We calculated the distance in kilometers from each ZIP code to the nearest CV-CTS, stratifying our results based on urban/rural setting, sex and race.
We identified a total of 10,506 studies in 4,630 US ZIP codes (10.5 %), of those only 237 (5 %) were rural. The overall median CV-CTS distance was 5.8 km (IQR: 2.7, 15.8). For urban residents, this distance was 4.5 km (IQR: 2.3, 9.2), while for rural residents, it was 24.2 km (IQR: 13.8, 42.2).
We revealed important disparities involving geographical proximity to cardiovascular clinical trial sites. Increasing the representation of these populations in clinical trials is paramount to improving the applicability of their findings to real-world settings.
Salerno PRVO
，Bourges-Sevenier B
，Chen Z
，Pereira GTR
，Deo S
，Nasir K
，Rajagopalan S
，Al-Kindi S
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《-》
Identifying and classifying anthropometric indicator for cardiovascular risk and coronary artery calcification: a protocol for a scoping review study.
Cardiovascular diseases are the main cause of mortality and disability worldwide, so the prevention becomes a priority in terms of public health. Therefore, it is necessary to use validated strategies to adequately identify these patients in daily clinical practice. The objective of this scope review is to comprehend and comprehensively describe the anthropometric indicators used in studies, such as such as weight, height, circumferences, lengths and skin folds, that address its association with coronary artery calcification to identify cardiovascular risk in the adult population.
Using Arksey and O'Malley's scoping review methodology as a guide, our scoping review of published reviews begins by searching several databases: Cochrane Central Register of Controlled Trials in the Cochrane Library, Medline Complete (EbscoHost), Embase, LILACS (Literatura Latino-Americana e do Caribe em Ciências da Saúde-BIREME Literatura Latino-Americana e do Caribe em Ciências da Saúde)and Web of Science and Scielo. As well as, it will be searched in the International Platform of the Registry of Clinical Trials of the WHO (www.who.int/ictrp); ClinicalTrials.gov; Transforming Research into Practice. Our team has formulated search strategies and two reviewers will independently screen eligible studies for final study selection. Bibliographic data and abstract content will be collected and analysed using a tool developed iteratively by the research team.
This protocol reports a comprehensive, rigorous and transparent methodology. This scoping review will be the first study to compare anthropometric measurements and coronary artery calcification, and thereby will contribute to the design and comparison of future studies in this field. This protocol reports a comprehensive, rigorous and transparent methodology. The results will be disseminated through a peer-reviewed publication. By identifying gaps in the current body of literature, this study can guide future research.
Frehner C
，Cunha NM
，Nagano FEZ
，Almeida CCB
，Junior EL
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《BMJ Open》
Impact of lesion length and vessel size on clinical outcomes after percutaneous coronary intervention with everolimus- versus paclitaxel-eluting stents pooled analysis from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent
The aim of this study was to investigate the impact of reference vessel diameter (RVD) and lesion length (LL) on the relative safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES).
Lesion length and RVD are well-known predictors of adverse events after percutaneous coronary intervention.
Patient-level data were pooled from the randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) trials. Quantitative angiographic core laboratory data were available for 6,183 patients randomized to EES (n = 3,944) or PES (n = 2,239). Long lesions and small vessels were defined as LL >median (13.4 mm) and RVD ≤median (2.65 mm), respectively. Major adverse cardiac events (MACE) (consisting of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) were assessed at 2 years, according to stent type in 3 groups: short lesions in large vessels (group A, n = 1,297); long lesions or small vessels but not both (group B, n = 2,981); and long lesions in small vessels (group C, n = 1,905).
The pooled 2-year MACE rates were 5.6%, 8.2%, and 10.4% in Groups A, B, and C, respectively (p < 0.0001). There was no significant interaction between lesion group and stent type (p = 0.64), indicating lower MACE with EES compared with PES regardless of LL and RVD. However, the absolute difference was largest in Groups B and C. In Group A, 2-year MACE rates were not significantly different between EES and PES (4.8% vs. 7.0%, respectively, p = 0.11). In contrast, EES was associated with lower 2-year rates of MACE in Group B (6.6% vs. 11.2%, p < 0.01) and in Group C (9.1% vs. 12.7%, p = 0.008) as well as lower rates of myocardial infarction, target lesion revascularization, and stent thrombosis. Multivariable analysis confirmed EES versus PES as an independent predictor of freedom from MACE in Groups B and C.
Patients with short lesions in large vessels have low rates of MACE at 2 years after treatment with either EES or PES. In higher-risk patients with long lesions and/or small vessels, EES results in significant improvements in both clinical safety and efficacy outcomes. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00180479; SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00307047; A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial; NCT01016041).
Claessen BE
，Smits PC
，Kereiakes DJ
，Parise H
，Fahy M
，Kedhi E
，Serruys PW
，Lansky AJ
，Cristea E
，Sudhir K
，Sood P
，Simonton CA
，Stone GW
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ResearchGate
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