Progression of Coronary Atherosclerosis in Asymptomatic Diabetic Subjects

NCT02109835 | Unknown DMC

• 1 other identifier: BCRT/3277/PROCEED
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of the study is to identify a sub-group of diabetic patients at higher risk of progression of coronary disease and also more likely to suffer from heart attack/angina and heart failure. The total number of patients to be recruited in this study will be 250 with type-2 diabetes but no known heart disease. These patients will have an objective measure of the function of the lining of the arteries, CT scan of the arteries of the heart and an ultrasound scan of the heart and arteries of the neck done at baseline along with blood tests for identification new markers of malfunction of the lining and inflammation of the arteries. Patients will be followed up at 18 months. During the follow-up visit, in addition to the blood tests, the CT scan of the heart arteries and ultrasound of the heart and arteries of the neck will be repeated to assess progression of the non-calcified, calcified and mixed plaques in the coronary arteries.

Conditions

Type 2 Diabetes; Coronary Artery Disease

Keywords

Diabetes; coronary artery disease; Cardiac computed tomography; Computed tomographics coronary angiography; Plaque progression

Outcome Measures

Primary Outcomes (1)

• Greater than 20% increase in plaque volume

  Plaque volume will be measured by both manual and semi-quantitative methods

  18 months

Secondary Outcomes (1)

• Greater than 20% increase in coronary artery calcium score

  18 months

Other Outcomes (3)

• Correlation between increase in plaque volume with levels of biomarkers

  18 months

• Correlation between carotid IMT measurements and coronary plaque

  18 months

• Incidence of major adverse cardiovascular events (MACE) during the 18-month follow-up period. MACE is defined as incidence of cardiac death, non-fatal myocardial infarction, STEMI and NSTEMI, unstable angina, late revascularization and onset of angina

  18 months

Study Arms (1)

Asymptomatic type 2 diabetes

Patients without previous history of coronary artery disease

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 2 diabetes recruited from hospital clinics and one community faith based cardiovascular disease prevention clinic run under the aegis of a lipidologist

You may qualify if:

• Established T2DM with or without micro-vascular complications of diabetes (retinopathy, peripheral neuropathy and/or micro-albuminuria)
• No history of coronary artery disease (CAD)

You may not qualify if:

• \. Estimated GFR \<45 2. Pregnant women 3. Age \< 35 years 4. Atrial fibrillation 5. Known allergy to iodine contrast 6. CAC score \>1000 Agatston Units

Sponsors & Collaborators

• British Cardiac Research Trust: lead
• Royal Free Hospital NHS Foundation Trust: collaborator
• London North West Healthcare NHS Trust: collaborator
• Barnet and Chase Farm Hospitals NHS Trust: collaborator
• Diabetes and Obesity Research Network: collaborator
• Lund University: collaborator
• Health Diagnostic Laboratory, Inc.: collaborator

Study Sites (5)

Central Middlesex Hospital

London, Middlesex, NW10 7NS, United Kingdom

RECRUITING

Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

NOT YET RECRUITING

Barnet Hospital

London, EN5 3DJ, United Kingdom

RECRUITING

University College London Hospitals

London, NW1 2BU, United Kingdom

NOT YET RECRUITING

Royal Free Hospital

London, NW3 2QG, United Kingdom

RECRUITING

Related Publications (6)

• 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.

  PMID: 16087647 BACKGROUND

• 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.

  PMID: 16682312 BACKGROUND

• 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.

  PMID: 18061069 BACKGROUND

• 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.

  PMID: 19448981 BACKGROUND

• 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.

  PMID: 24576983 BACKGROUND

• 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.

  PMID: 31014330 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and serum will be separated from the blood sample collected within half an hour. These samples will be labelled with the unique random number assigned to each patient recruited to the study. The link file with the random numbers and patient identifiers will be kept on single computer with restricted access to only members of the research team. Only the completely anonymised samples will be sent to the labs for analysis. 5 mls of whole blood with cells will also be stored.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Roby Rakhit, MD FRCP

  Royal Free Hospital NHS Foundation Trust

  STUDY CHAIR

• Avijit Lahiri, MRCP FACC

  Wellington Hospital

  STUDY DIRECTOR

• Daniel Darko, MRCP

  Central Middlesex Hospital

  PRINCIPAL INVESTIGATOR

• Mark Cohen, PhD FRCP

  Barnet Hospital

  PRINCIPAL INVESTIGATOR

• Rajiv A Amersey, MD FRCP

  Whipps Cross Hospital

  PRINCIPAL INVESTIGATOR

• Sarita Naik, DM MRCP

  University College London Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shreenidhi M Venuraju, MRCP

CONTACT

+442074835062; shreenidhimv@gmail.com

Anand Jeevarethinam, MRCP

CONTACT

+442074835062; dr.anand2812@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: September 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2017
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

GB (5)