Diabetes MellitusNCT03394313
Qatar Cardiometabolic Registry
An observational study of Diabetes Mellitus and Cardiovascular Diseases, run by Hamad Medical Corporation at 1 site in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Cardiovascular Diseases
- How many people
- 50,000 participants
- Where
- 1 siteQatar
- Study dates
- 15 Sep 2017to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with type 2 diabetes mellitus and cardiovascular disease
Who may be able to join
- Patients with type 2 diabetes mellitus
- Newly diagnosed heart disease, such as ischemic heart disease, heart failure.
Who cannot join
- Patients who do not have type 2 diabetes mellitus
- Preexisting heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rajvir Singh, Ph.D contact
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Coorporation
Doha, 3050
Jassim Al-Suwaidi, MD, 55823041
About this study
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.
Read the 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
- Keywords
- Registry
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: Ten years (15/09/2017 to 31/12/2027)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start15 Sep 2017
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jassim Al-Suwaidi, MD, Principal investigator, Hamad Medical Coorporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394313
- Sponsor's protocol ID
- MRC-01-17-003
- Status last verified
- Dec 2017
- First submitted
- 1 Jan 2018
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20195771Kucharska-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.
PubMed 19855920Martin-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.
PubMed 25126392Shah 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.
PubMed 25466521
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qatar Cardiometabolic Registry
- ClinicalTrials.gov ID
- NCT03394313
- Acronym / sponsor ID
- MRC-01-17-003
- Conditions
- Diabetes Mellitus, Cardiovascular Diseases
- Keywords
- Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes mellitus and cardiovascular disease
Key inclusion criteria (2 listed)
- Patients with type 2 diabetes mellitus
- Newly diagnosed heart disease, such as ischemic heart disease, heart failure.
Key exclusion criteria (2 listed)
- Patients who do not have type 2 diabetes mellitus
- Preexisting heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: Ten years (15/09/2017 to 31/12/2027)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Background: PubMed 20195771Siscovick 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.
- Background: PubMed 19855920Kucharska-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.
- Background: PubMed 25126392Martin-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.
- Background: PubMed 25466521Shah 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajvir Singh, Ph.D contact
Jassim Al-Suwaidi, MD principal investigator
Hamad Medical Coorporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Cardiovascular Diseases, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jassim Al-Suwaidi, MD (55823041, jalsuwaidi@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Ten years (15/09/2017 to 31/12/2027)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03394313, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018; AzTrials last refreshed its copy on 29 Oct 2026.