Cardiovascular Diseases Clinical Trial
Official title:
Qatar Cardiometabolic Registry
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.
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.
Exclusion criteria: Subjects who do not have T2DM and existing heart disease will be excluded
from the registry.
The treating physicians will enter the list of patients attended his clinic to Power Trial.
The study investigators will update the list of the patients attended the cardio-metabolic
clinic on daily basis and the registry will transfer the information from the Cerner to the
registry database. The clinical service has been start from September 15, 2017, and each
patient who attended the clinic will be added to the registry.
This registry is prospectively collecting the information from Cerner Clinical Viewer. For
future research the investigators who wish to utilize the registry data for their research
will have to seek Institutional Review Board (IRB) approval for their research proposal.
Informed Consent Informed consent will be obtained from each patient who will attend the
cardiometabolic clinic to allow us to capture his clinical information into the registry
database.
Subject Withdrawal/ Withdrawal of Consent If the subjects withdraw his consent, the
information about his future follow-up visits in the clinic will not be added to the
registry. However, previous data added to the registry will continue to be available.
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