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临床试验/NCT03394313
NCT03394313招募中不适用

Qatar Cardiometabolic Registry

Hamad Medical Corporation1 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2017年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50,000
试验地点
1
主要终点
Mortality

研究概览

简要总结

Type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD) are closely related. T2DM risk equivalent for CVD and it remains the major cause of death in T2DM. Thus, patients with T2DM and CVD disease are at very high-risk of CVD-related mortality. Therefore, more aggressive metabolic and hemodynamic control is required in such patients to improve the prognosis. We recently initiated a cardio-metabolic clinical service at the Heart Hospital, where T2DM patients with existing CVD are simultaneously examined by Cardiologist and Diabetologist for optimal metabolic and hemodynamic control. We would like to start a clinical registry for all patients who attend this clinical service to collect import clinical data about this population. This registry will serve an important source for future clinical research in the field.

详细描述

Various investigators have shown that type 2 diabetes is associated with out-of-hospital cardiac arrest and mortality due sudden cardiac arrest [1,2]. In comparison to non-diabetic patients, those with T2DM possess greater risk of cardiovascular morbidity and deaths, and are considerably influenced by cardiovascular disease [3]. To assess the potential benefit of T2DM prevention and treatment, as well as the future burden of T2DM-associated diseases can help in better understanding of the T2DM and the risk of chronic cardiovascular manifestations is warranted [4]. Herein, we would like to start a clinical registry for all patients who attend this clinical service to collect import clinical data about this population. This registry will serve an important source for scientific information that can be used in future to design clinical research studies for better patient care and management.

The cardio-metabolic clinic has been recently established in the Heart Hospital to provide state-of-the-art care for patients with T2DM and established heart disease, e.g. ischemic heart disease, heart failure, etc. the health information of all patients attending the cardio-metabolic Clinic for the care of their disease who provide their consent for the use of their health information in the registry will be added to the registry.

A data base for this registry will be created in Cerner which will be password protected. Clinical information about patients attending the cardiometabolic clinic in the Heart Hospital will be collected. Data will include demographics (age, gender, and nationality), vital signs (Pulse rate, blood pressure), waist circumference , Weight, Canadian Cardiovascular Society (CCS) Class, New York Heart Association ( NYHA) class, history of hospitalization for chest pain, shortness of death, Stent thrombosis, syncope or Dizzy spells, Stroke, Transient Ischemic Attack (TIA), Polyurea, urinary tract infection, Activity Level, Foot exam, Peripheral pulses, Mono-filament exam, Ankle Brachial Index test, Cardiac Rehabilitation, Diabetes monitoring at home, Insulin Pump, Revascularization Needed, angiogram and presentation (Presenting Acute Coronary Syndrome (ACS), ST-Elevation Myocardial Infarction (STEMI), Upstream antiplatelets, Culprit artery, Non-ST-Elevation Myocardial Infarction (NSTEMI), Stent-No1, Unstable angina, Known Diabetes, Stent-No2, Newly diagnosed DM, Stent-No3, Hypertension, Total No of Stent, Tobacco use, Type of Stent, Thrombectomy, Troponin highest level, EUROScore, Reopro, Coronary angiogram, Thrombosis in Myocardial Infarction (TIMI) flow, Dissection, Perforation, Syntax Score Coronary Artery Disease (SYNTAXSCORE), Left Main Coronary Artery (LM), Loss of side branch, Access type, Left Anteriour Descending Artery (LAD), D1, Seal Device, D2, Left Circumflex (LCx), First Obtuse Marginal (OM1), Second Obtuse marginal (OM2), Right CoronaryArtery (RCA), Patent Ductus Arteriosus (PDA), Percutaneous Coronary Intervention (PCI), PCI-LAD, PCI-D1, PCI-D2, PCI-LCx, PCI-OM1, PCI-OM2, PCI-RCA, PCI-PDA, Drug Eluted Stent (DES), Bare Metal Stent (BMS), BMS, Total number of stents, Coronary Artery Bypass Surgery (CABG), Trp post PCI-24, Creatinine-48 post PCI, Stent thrombosis), laboratory findings, history of diabetes (type 1 and 2), Gastroparesis, Erectile dysfunction, Metabolic Syndrome, chronic kidney disease, Chronic Liver Disease, Gestational DM, Diabetic ketoacidosis, hypoglycemia, Hyperosmolar Hyperglycemic Syndrome, Depression, Hypertension, Peripheral Arterial disease, Peripheral Arterial Disease (PAD)- Acute limb ischemia, PAD-Claudication, PAD Critical Limb Ischemia, PAD-Cellulitis, PAD-Lower Limb osteomyelitis, Hemorrhage, Intracranial Hemorrhage, Stroke, Hemorrhagic, Ischemic, Carotid Endarterectomy, carotid Endarterectomy (CEA)-Left, CEA-Right, Carotid stenting, Amputation, Above knee Amputation, Amputation foot, Amputation of Toe, PAD Bypass, PAD intervention, medications.

Study population:

Inclusion criteria: patients with T2DM and established heart disease, such as ischemic heart disease, heart failure, etc. will be included in the study after obtaining the informed consent.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with type 2 diabetes mellitus
  • Newly diagnosed heart disease, such as ischemic heart disease, heart failure.

排除标准

  • Patients who do not have type 2 diabetes mellitus
  • Preexisting heart disease

结局指标

主要结局

Mortality

时间窗: Ten years (15/09/2017 to 31/12/2027)

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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