Plain English Summary
Background and study aims:
Atherosclerosis is a serious disease where a fatty substance, called plaque, buildsup in the arteries. Over time, plaque causes hardening and narrowing of the arteries, which leads to reduced flow of blood through the blood vessels. It is a major cause of cardiovascular disease (disease of the heart and/or blood vessels) which can lead to potentially fatal complications such as heart attack or stroke (major cardiovascular events). Over the last 20 years, the death toll from cardiovascular disease (CVD) has decreased, however for those with type 2 diabetes (a condition in which people are unable to control their blood sugar) have a higher risk of dying from CVD than non-diabetic patients. In addition, patients with type 2 diabetes have a higher risk of developing complications if they undergo surgery on the heart or blood vessels. Currently, little is known about the effect of undiagnosed type 2 diabetes on the risk of dying from complications relating to CVD, and the only data available only looks at the effects in the short-term. The Tor Vergata Atherosclerosis Study has been designed to follow patients with previous CVD and evaluate the risk of new CVD events through the creation of a registry. The aim of this registry is to investigate the extent to which undiagnosed diabetes and atherosclerosis severity affect the occurrence of a second major cardiovascular event in high risk individuals. The aim of this study is to follow patients for 20 years in order to find out whether problems controlling blood sugar are related to death from CVD.
Who can participate?
Male and female patients aged between 40-85 years with atherosclerosis.
What does the study involve?
At the start of the study, participants undergo a metabolic assessment. Participants then receive yearly follow up calls for the next 20 years to assess how many die, how many die from CVD and how many have a non-fatal cardiovascular event (such as a heart attack or stroke).
What are the possible benefits and risks of participating?
A potential benefit of taking part in the study is that any problems with the way the body processes glucose (sugar) will be identified. There are no significant risks of participating.
Where is the study run from?
Center for Atherosclerosis, University Hospital of Rome Tor Vergata (Italy)
When is study starting and how long is it expected to run for?
January 2007 to December 2027
Who is the main contact?
Professor Massimo Federici
federicm@uniroma2.it
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TVAR 1
Study information
Scientific title
Tor Vergata Atherosclerosis Registry: a cohort study to understand the links between glucose and metabolic disorders and cardiovascular mortality
Acronym
TVAR
Study hypothesis
Undiagnosed glucose metabolism increases cardiovascular mortality.
Ethics approval
Ethic Committee University Hospital Tor Vergata - Rome, 29/04/2008
Study design
Observational longitudinal study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Atherosclerosis and diabetes
Intervention
Patients enrolled in the study will undergo a metabolic assessment at baseline to evaluate the degree of glucose impairment.
The basal metabolic assessment include:
1. Fasting plasma glucose, fasting plasma insulin, glycated Hemoglobin (HbA1c) and C-peptide levels, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides and indexes of insulin resistance, such as HOMA IR, QUICKI, Matsuda index, and HOMA beta index for insulin secretion in diabetic patients.
2. Fasting plasma glucose, fasting plasma insulin, glycated Hemoglobin (HbA1c) and C-peptide levels, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides and indexes of insulin resistance, such as HOMA IR, QUICKI, Matsuda index, and HOMA beta index for insulin and oral glucose tolerance test (OGTT) in non diabetic patients.
In patients that undergo Carotid Artery Endoarterectomy, atherosclerotic plaques are collected. The atheroma is then divided in two parts: one part was preserved in formalin for histology analysis and the other part was immersed in liquid nitrogen for further analysis.
The follow-up will be performed annually by phone in order to investigate the occurrence of new fatal or non-fatal cardiovascular events. The total duration of observation will be for 20 years.
Intervention type
Other
Phase
Drug names
Primary outcome measures
1. Mortality is measured using the phone interview confirmed by hospital records at yearly follow-up
2. Cardiovascular mortality is measured using the phone interview confirmed by hospital records at yearly follow-up
Secondary outcome measures
Non-fatal cardiovascular events (AMI and Stroke) are measured using the phone interview confirmed by hospital records at yearly follow-up.
Overall trial start date
01/01/2007
Overall trial end date
31/12/2025
Reason abandoned
Eligibility
Participant inclusion criteria
Patients were diagnosed with established and documented atherosclerotic vascular disease at the atherosclerosis ambulatory clinic that includes cardiology, diabetology and vascular surgery specialists. All the patients have had a major CV event or undergone a vascular procedure for significant vascular stenosis.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1000
Participant exclusion criteria
1. Liver disease
2. Renal insufficiency
3. Heart failure
4. Coagulopathy
5. Any other severe systemic disease
6. Positive blood tests for HIV, hepatitis B, or hepatitis C
Recruitment start date
01/01/2007
Recruitment end date
31/12/2015
Locations
Countries of recruitment
Italy
Trial participating centre
University Hospital of Rome Tor Vergata
Center for Atherosclerosis
Via Montpellier
Rome
00133
Italy
Funders
Funder type
University/education
Funder name
University of Rome Tor Vergata (Università degli Studi di Roma Tor Vergata)
Alternative name(s)
University of Rome Tor Vergata
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Italy
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
Intention to publish date
31/12/2027
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary