Progression of Coronary Atherosclerosis in Asymptomatic Diabetic Subjects
NCT ID: NCT02109835
Last Updated: 2015-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
250 participants
OBSERVATIONAL
2012-09-30
2017-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of the Effect of Diabetes on the Incidence and the Extent of Coronary Artery Disease
NCT01585948
Clinical Observation of Coronary Arterial Microcirculation Dysfunction in Diabetic Patients With Non- Obstructive Coronary Artery Disease
NCT02748980
Carotid Atherosclerosis and Vascular Events in People With Diabetes
NCT02929355
Screening For Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography, Following Core 64
NCT00488033
Evaluating Atherosclerotic Disease Progression in Patients With Diabetes Mellitus
NCT07237685
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Previous studies using coronary calcium scanning in diabetic patients showed that those with the greatest progression in calcified plaque in the coronary arteries were at the highest risk for heart attacks. However, coronary calcium scans only identify the calcified plaque and are not able to pick up non-calcified, cholesterol rich plaques. Cholesterol rich non-calcified plaques are more often associated witn acute heart attacks. CT coronary angiography can identify both calcified and non-calcified plaques and can therefore add significantly to our predictive ability. Certain chemical substances (biomarkers) measured in blood indicate the severity of plaque burden and inflammation in the coronary arteries. A combination of CT coronary angiography, expression of genetic markers, measure of function of the cells lining the blood vessels and biomarkers can help to identify diabetic patients at highest risk of heart attacks, allowing us to start appropriate risk reduction treatments in those patients. In previous studies with coronary artery calcium, patients suffering from heart attacks were those who also had a higher progression of coronary artery calcium (CAC) score. In diabetics, in particular, patients with poor control of their blood glucose also had greater progression of the CAC score. In order to test the validity of our hypothesis, we have decided to base our study on a population of established diabetics with difficult to control blood pressure, high cholesterol and chronic complications of the small blood vessels, i.e. involvement of the retina (back of the eye) and peripheral nerves as well as protein in the urine. Patients with chronic complications of diabetes are known to have higher incidence of heart disease as well.
Methodology and Timetable: Patients will be recruited from Diabetes clinics of NHS hospitals in North West London.
If eligible for the trial, an informed consent will be obtained from the patients and their general practitioner will be subsequently informed about their participation in the trial. Once recruited into the trial, a CT coronary angiogram (CTCA, CT of the arteries of the heart), ultrasound scan of the heart and carotid arteries of the neck as well as a measure of endothelial function will be performed at the Wellington Hospital in St. Johns Wood, London within 1-2 weeks. At the same time, blood samples will also be obtained for bio-markers. A report of the CTCA will then be forwarded to the consultant in-charge of the patient's care as well as to the GP.
If a narrowing of moderate degree (70%) is noted on the CT angiogram, the patient will then be brought back to the Wellington Hospital within 2 weeks for a heart perfusion scan which evaluates the relative discrepancies in flow of blood to the heart muscle and helps plan further management.
If there is significant reduction in blood flow noted in the perfusion scan,patients will be referred back to the consultants for further clinical management.
During their first visit to the Wellington Hospital for the CT scan, blood samples will be taken and stored on-site for biomarker analysis.
Patients will be followed up after 18 months from the time of recruitment into the trial,when a second CTCA, ultrasound of the arteries of the neck will be performed to assess the degree of progression of calcium and cholesterol deposits within the coronary arteries and thickness of the lining of the arteries in the neck in addition to blood sample collection for bio-markers.
Patients with significant narrowing of coronary arteries (\>70%) requiring a stent to be inserted in the first scan will be excluded from follow up. Patients with normal coronary arteries on the initial scan also will be excluded from the follow-up.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Asymptomatic type 2 diabetes
Patients without previous history of coronary artery disease
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
No history of coronary artery disease (CAD)
Exclusion Criteria
35 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Royal Free Hospital NHS Foundation Trust
OTHER
London North West Healthcare NHS Trust
OTHER
Barnet and Chase Farm Hospitals NHS Trust
OTHER
Diabetes and Obesity Research Network
NETWORK
Lund University
OTHER
Health Diagnostic Laboratory, Inc.
INDUSTRY
British Cardiac Research Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Roby Rakhit, MD FRCP
Role: STUDY_CHAIR
Royal Free Hospital NHS Foundation Trust
Avijit Lahiri, MRCP FACC
Role: STUDY_DIRECTOR
Wellington Hospital
Daniel Darko, MRCP
Role: PRINCIPAL_INVESTIGATOR
Central Middlesex Hospital
Mark Cohen, PhD FRCP
Role: PRINCIPAL_INVESTIGATOR
Barnet Hospital
Rajiv A Amersey, MD FRCP
Role: PRINCIPAL_INVESTIGATOR
Whipps Cross Hospital
Sarita Naik, DM MRCP
Role: PRINCIPAL_INVESTIGATOR
University College London Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Central Middlesex Hospital
London, Middlesex, United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Barnet Hospital
London, , United Kingdom
University College London Hospitals
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Anand DV, Lim E, Lahiri A, Bax JJ. The role of non-invasive imaging in the risk stratification of asymptomatic diabetic subjects. Eur Heart J. 2006 Apr;27(8):905-12. doi: 10.1093/eurheartj/ehi441. Epub 2005 Aug 8.
Anand DV, Lahiri A, Lim E, Hopkins D, Corder R. The relationship between plasma osteoprotegerin levels and coronary artery calcification in uncomplicated type 2 diabetic subjects. J Am Coll Cardiol. 2006 May 2;47(9):1850-7. doi: 10.1016/j.jacc.2005.12.054. Epub 2006 Apr 19.
Anand DV, Lim E, Darko D, Bassett P, Hopkins D, Lipkin D, Corder R, Lahiri A. Determinants of progression of coronary artery calcification in type 2 diabetes role of glycemic control and inflammatory/vascular calcification markers. J Am Coll Cardiol. 2007 Dec 4;50(23):2218-25. doi: 10.1016/j.jacc.2007.08.032. Epub 2007 Nov 19.
Fredrikson GN, Anand DV, Hopkins D, Corder R, Alm R, Bengtsson E, Shah PK, Lahiri A, Nilsson J. Associations between autoantibodies against apolipoprotein B-100 peptides and vascular complications in patients with type 2 diabetes. Diabetologia. 2009 Jul;52(7):1426-33. doi: 10.1007/s00125-009-1377-9. Epub 2009 May 12.
Jeevarethinam A, Venuraju S, Weymouth M, Atwal S, Lahiri A. Carotid intimal thickness and plaque predict prevalence and severity of coronary atherosclerosis: a pilot study. Angiology. 2015 Jan;66(1):65-9. doi: 10.1177/0003319714522849. Epub 2014 Feb 26.
Venuraju SM, Lahiri A, Jeevarethinam A, Cohen M, Darko D, Nair D, Rosenthal M, Rakhit RD. Duration of type 2 diabetes mellitus and systolic blood pressure as determinants of severity of coronary stenosis and adverse events in an asymptomatic diabetic population: PROCEED study. Cardiovasc Diabetol. 2019 Apr 23;18(1):51. doi: 10.1186/s12933-019-0855-8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BCRT/3277/PROCEED
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.