Role of depression in blood pressure control. A cross-sectional multicentric study.

RESEARCH PROBLEM: Hypertension is a multifactorial disease that affects approximately one third of the Tunisian adult population. It is a major risk factor for stroke and cardiovascular disease. Environmental and psychosocial factors play an important role in hypertension onset and control. The prevalence of depression among hypertensive patients is 26, 8% and its presence is associated with increased risk of cardiovascular related morbi-mortality. Our study aims to evaluate the role of depression in blood pressure control among ambulatory hypertensive patients. Investigative process: This study is a cross-sectional, multicentric and descriptive study. We intend to include three hundred and two patients. A 24-hour ambulatory blood pressure monitor will be used to evaluate blood pressure control. Depression will be assessed by the 9-item Patient Health Questionnaire (PHQ-9) in Tunisian dialect. Clinical, socio-environmental, psychosocial and therapeutic and prognosis data will be collected from medical records. Patients will be classified into two groups: Controlled versus non-controlled hypertension. PHQ-9 scores will be then compared between the two cohorts. RESEARCH PLAN: Ethical considerations will be undertaken and respected. All patients should express an informed oral consent before enrollment. This trial will run for three months from the 15th August 2022. TRIAL REGISTRATION: NCT05516173.

Simulation versus theoretical learning for the transradial approach: a randomized controlled trial in interventional cardiology.

INTRODUCTION: Simulation-based education (SE) in interventional cardiology improves knowledge acquisition and mastery of procedures including the conventional radial access (CRA). AIM: To evaluate the contribution of SE in CRA compared with theoretical learning alone. METHODS: This is a prospective randomized controlled study including cardiology residents and patients with normal radial pulses. Experienced residents as well as patients with contraindications to CRA, requiring urgent intervention, or with hemodynamic instability were not included. Missing the teaching sessions was the exclusion criteria. Residents were randomized into two groups: simulation versus control. They attended a theory lecture explaining CRA and were evaluated Only the simulation group attended an SE session with measurement of heart rate (HR) and stress level. A real application was then performed with measurement of HR and stress level. The primary outcome was success puncture rate. RESULTS: The success of the puncture was similar between the two groups (p=0.651). In the practical application, the stress level was significantly different before the procedure but similar after the end of the procedure. The stress level varied significantly within the same group before and after the procedure The simulation group was significantly less tachycardic both before and during the procedure with a significant difference between the two groups (p <10-3). CONCLUSION: This study demonstrated the interest of SE in novice residents for CRA as a complement to theoretical learning upstream of the real-life procedure.

Evaluation of the distal radial approach in percutaneous coronary interventions. A controlled, randomized non-inferiority trial.

INTRODUCTION: The conventional radial approach (CRA), the gold standard approach for percutaneous coronary interventions (PCI), is associated with the risk of radial artery occlusion (RAO). The distal radial approach (DRA) is an effective alternative with fewer complications. AIM: To evaluate the efficacy in terms of puncture success and safety by RAO rate of the DRA in elective PCI in Tunisian patients. METHODS: It was a randomized controlled non-inferiority trial including patients hospitalized for elective PCI. The protocol was previously published (Tunis Med 2022; 100(3): 192-202). The primary endpoints were puncture success and RAO rate at 30 days. RESULTS: Overall, 250 patients were included and the groups were comparable. The preprocedural examination of the radial pulse and the Barbeau test were similar. The majority of PCIs were coronary angiography (82%). In ITT, respectively in CRA versus DRA, puncture success rates were similar (97.6% versus 96.8%; p≤0.500). RAO rates were similar (2.4% versus 3.2%; p≤0.500). Crossovers were similar. PCI through DRA lasted longer but was not more irradiating, however it required more contrast. Overall bleeding and vascular complications were similar. CONCLUSION: This study demonstrated the non-inferiority of DRA compared to CRA for elective PCIs in a Tunisian population regarding puncture success and RAO rate at 30 days. Multicenter trials including urgent PCI with systematic ultrasound screening for RAO are needed.

Evaluation of the Distal Radial Approach in percutaneous coronary interventions. Controlled, randomized non-inferiority trial.

RESEARCH PROBLEM: The conventional radial approach is the recommended vascular access for percutaneous coronary interventions. It is effective and feasible but associated with a risk of occlusion of the radial artery. The distal radial approach is proposed as a new approach to reduce complications and preserve the radial artery. However, few clinical trials in real life were conducted in North African patients. This trial aims to evaluate the efficacy and safety of the distal radial approach versus the conventional radial approach. Investigative process : This trial is a non-inferiority, randomized controlled trial with two parallel arms: distal radial approach and conventional radial approach. Two hundred fifty patients scheduled for percutaneous coronary intervention will be included. The two main endpoints are the puncture success rate with a non-inferiority margin of 10% and the occlusion rate of the punctured radial artery attributed to the end of hemostasis and to 30 days. Secondary Endpoints : catheterization success, crossover rate, procedure time, radial artery spasm, bleeding complications, QuickDASH pain score, Operator satisfaction. A single blind analysis will be led according to the per-protocol and intention-to-treat methods. RESEARCH PLAN: Ethical considerations will be undertaken and respected. This trial will run for four months from February 2022. The results will provide parameters related to the efficacy and safety of the distal radial approach, improving clinical practice. TRIAL REGISTRATION: NCT05311111.

Drug-Eluting-Balloon Angioplasty in Tunisian population versus Everolimus-platinum-chrome-stent for de-novo coronary lesion.

RESEARCH PROBLEM: Drug-eluting balloon (DEB) angioplasty is a well-established treatment modality for in-stent restenosis, however its safety and efficacy in de-novo lesion especially in large vessel remains undetermined. Theoretically, DEB sight to eliminate stent thrombosis and reduce restenosis rates by leaving no metal behind. AIM: To compare the results of angioplasty of de novo lesions by DEB (SEQUENT PLEASE) versus DES (Promus Premier and Promus Elite) in a Tunisian population. THE ENDPOINTS will be primarily the Late Lumen Loss at 12 months and secondarily the Major Cardiovascular Event rate (MACE) at 12 months. INVESTIGATIVE PROCESS: This is a randomized controlled non-inferiority trial including 290 patients with chronic coronary disease or non-ST elevation myocardial infarction with de novo lesions. After coronarography, angiographic parameters concerning lesion location and quantitative analysis will be collected. Patients will be treated with DEB or DES according to their allocation group. Before removal of the guide, post-procedural angiographic parameters will be evaluated. Follow-up will be performed for 12 months and an angiographic examination will be performed either as an emergency or at 12 months. The significance level will be 5%. A univariate analysis will be performed to search for predictive factors of MACE. RESEARCH PLAN: Ethical considerations will be undertaken and respected. The study will run for 15 months starting August 25, 2021 Trial registration: NCT05516446.