Qatar Cardiometabolic Registry

NCT ID: NCT03394313

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Diabetes Mellitus; Cardiovascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jassim Al-Suwaidi, MD

Role: PRINCIPAL_INVESTIGATOR

Hamad Medical Coorporation

Locations

Hamad Medical Coorporation

Doha, , Qatar

Site Status: RECRUITING

Countries

Qatar

Central Contacts

Jassim Al-Suwaidi, MD

Role: CONTACT

jalsuwaidi@hamad.qa

55823041

Rajvir Singh, Ph.D

Role: CONTACT

rsingh@hamad.qa

Facility Contacts

Jassim Al-Suwaidi, MD

Role: primary

55823041

References

Siscovick DS, Sotoodehnia N, Rea TD, Raghunathan TE, Jouven X, Lemaitre RN. Type 2 diabetes mellitus and the risk of sudden cardiac arrest in the community. Rev Endocr Metab Disord. 2010 Mar;11(1):53-9. doi: 10.1007/s11154-010-9133-5.

Reference Type: BACKGROUND

PMID: 20195771 (View on PubMed)

Kucharska-Newton AM, Couper DJ, Pankow JS, Prineas RJ, Rea TD, Sotoodehnia N, Chakravarti A, Folsom AR, Siscovick DS, Rosamond WD. Diabetes and the risk of sudden cardiac death, the Atherosclerosis Risk in Communities study. Acta Diabetol. 2010 Dec;47 Suppl 1(Suppl 1):161-8. doi: 10.1007/s00592-009-0157-9. Epub 2009 Oct 24.

Reference Type: BACKGROUND

PMID: 19855920 (View on PubMed)

Martin-Timon I, Sevillano-Collantes C, Segura-Galindo A, Del Canizo-Gomez FJ. Type 2 diabetes and cardiovascular disease: Have all risk factors the same strength? World J Diabetes. 2014 Aug 15;5(4):444-70. doi: 10.4239/wjd.v5.i4.444.

Reference Type: BACKGROUND

PMID: 25126392 (View on PubMed)

Shah AD, Langenberg C, Rapsomaniki E, Denaxas S, Pujades-Rodriguez M, Gale CP, Deanfield J, Smeeth L, Timmis A, Hemingway H. Type 2 diabetes and incidence of cardiovascular diseases: a cohort study in 1.9 million people. Lancet Diabetes Endocrinol. 2015 Feb;3(2):105-13. doi: 10.1016/S2213-8587(14)70219-0. Epub 2014 Nov 11.

Reference Type: BACKGROUND

PMID: 25466521 (View on PubMed)

Other Identifiers

MRC-01-17-003

Identifier Type: -

Identifier Source: org_study_id