Condition category
Circulatory System
Date applied
28/06/2016
Date assigned
19/10/2016
Last edited
26/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Massimo Federici

ORCID ID

Contact details

University of Rome Tor Vergata
Department of Systems Medicine
Via Montpellier 1
Rome
00133
Italy

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

Sponsor information

Organisation

University of Rome Tor Vergata Department of Systems Medicine

Sponsor details

Via Montpellier 1
Rome
00133
Italy

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

26/10/2016: internal edit.