Objectives: 1. To what extent does the CVRM risk profile and co-morbid conditions differ between individuals with (UCC-SMART) and without (UHP-UCC) symptoms of heart failure, but with similar levels of echocardiographic structural- and functional…
ID
Source
Brief title
Condition
- Heart failures
- Nephropathies
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For the 1st research question: To what extent does the CVRM risk profile and
co-morbid conditions differ between individuals with (UCC-SMART) and without
(UHP-UCC) symptoms of heart failure, but with similar levels of
echocardiographic structural- and functional measurements?
The main outcome is: presence (and absence) of symptomatology belonging to
potentially heart failure combined with referral to UMC Utrecht, assessed with
the Heart Failure symptoms questionnaire.
The main determinants are: CVRM profile and co-morbidity
Potential confounders: age, sex, level of left ventricular dimensions and
ejection fraction.
For the 2nd research question: To what extent does the CVRM profile and
co-morbid conditions differ between individuals without cerebral ischemic
symptoms (UHP) from those with symptoms of cerebral ischemia (UCC-SMART), given
a similar level of carotid structural and functional values?
The main outcome is: presence (and absence) of symptomatology belonging
cerebral ischemia based on questionnaire data combined with referral to the UMC
Utrecht
The main determinants are: CVRM profile and co-morbidity
Potential confounders: age, sex, level of carotid atherosclerosis.
For the 3rd research question: To what extent does Ideal Cardiovascular Health,
assessed by 7 cardiovascular health metrics defined by the American Heart
Association, differ between those with (UCC-SMART) and without (UHP-UCC)
symptoms of CVD, but with similar levels of cardiac, aortic and carotid
structural abnormalities?
The main outcome is: presence (and absence) of symptomatology belonging
vascular disease based on questionnaire data combined with clinical information
from GP and/or UMC Utrecht
The main determinants are: CVRM profile and co-morbidity
Potential confounders: age, sex, level of subclinical disease of the heart, the
carotid artery and the aorta.
For the 4th research question: To what extent does the CVRM risk profile and
co-morbid conditions differ between diabetic patients treated by the general
practitioner (UHP-UCC) from those treated by the specialist (UCC-SMART), given
similar level of glycemic control and level of subclinical vascular disease) ?
The main outcome is: diabetics treated by the GP or in the UMC Utrecht
The main determinants are: CVRM profile and co-morbidity
Potential confounders: age, sex, level of glycaemic control and subclinical
vascular disease (cardiac/carotid/aorta)
For the 5th research question: To what extent does the CVRM risk profile and
co-morbid conditions differ between hypertensive patients treated by the
general practitioner (UHP-UCC) from those treated by the specialist
(UCC-SMART), given similar level of blood pressure control?
The main outcome is: hypertension treated by the GP or in the UMC Utrecht
The main determinants are: CVRM profile and co-morbidity
Potential confounders: age, sex, level of blood pressure.
Secondary outcome
n.v.t.
Background summary
The Utrecht Health Project (UHP) is an ongoing primary care-based cohort study
among patients enlisted with academic general practice centers affiliated with
the Julius Center, University Medical Center Utrecht, the Netherlands. Patients
from a recently developed residential area, Leidsche Rijn, suburb of Utrecht,
are invited to come in for an *individual health profile* (IHP). The study is
described more extensively elsewhere.2 In short, all participants receive a
general health questionnaire, and information is obtained on medical history,
current medication use, and lifestyle. Height and weight are measured and
cholesterol and glucose are determined. Blood pressure is measured on the
dominant arm with an Omron M4 device. A blood sample is stored in the UMC
Utrecht Biobank. Follow-up is performed through linkage with the general
practitioner records. Inclusion of participants in the UHP started in 2000. The
UHP has been approved by the UMC Utrecht Institutional Review Board (protocol
99/240). Informed consent is obtained from all participants. Since 2014,
harmonization of UCC-CVRM and UHP has already performed in terms of
measurements and informed consent.
UCC-CVRM provides an infrastructure for uniform registration of guideline based
cardiovascular information embedded in routine care and for systematic
follow-up of these patients.1 Furthermore, UCC-CVRM was designed to be linked
with cohort information from the UHP. The notion is that the inclusion of the
full spectrum of subjects from healthy to severely diseased expands generation
of knowledge (scientific evidence) on the development of the various phases of
vascular disease, the main drivers of the change from asymptomatic to
symptomatic conditions, and the consequences in terms of referral, use of
general practice and hospital health care facilities, morbidity and mortality.
With the additional data collection in the UHP-UCC project in close
collaboration with UCC-SMART and UCC-CVRM, we now describe a limited number of
dedicated research projects that constitute part of the rationale for this
submission. These questions closely fit within the research priorities of the
Leidsche Rijn Academic Julius Health Care Centers and the UMC Utrecht Center of
Circulatory Health. Yet, we realize that the data that will be collected with
the information of the combined cohorts could and will address many more
research questions once the data has been collected. As such, the structure
needed for this proposal serves a wider scope than the research questions as
described below.
Study objective
Objectives:
1. To what extent does the CVRM risk profile and co-morbid conditions differ
between individuals with (UCC-SMART) and without (UHP-UCC) symptoms of heart
failure, but with similar levels of echocardiographic structural- and
functional measurements?
2. To what extent does the CVRM profile and co-morbid conditions differ between
individuals without cerebral ischemic symptoms (TIA or ischemic cortical
stroke) (UHP) from those with symptoms of cerebral ischemia (UCC-SMART), given
a similar level of carotid structural- and functional measurements?
3. To what extent does Ideal Cardiovascular Health, assessed by 7
cardiovascular health metrics defined by the American Heart Association, differ
between those with (UCC-SMART) and without (UHP-UCC) symptoms of CVD, but with
similar levels of cardiac and carotid structural abnormalities?
4. To what extent does the CVRM risk profile and co-morbid conditions differ
between patients treated by the general practitioner (UHP-UCC) from those with
diabetes treated by the specialist (UCC-SMART), given similar level of
glycaemic control and level of subclinical vascular disease?
5. To what extent does the CVRM risk profile and co-morbid conditions differ
between hypertensive patients treated by the general practitioner (UHP-UCC)
from those treated by the specialist (UCC-SMART), given similar level of blood
pressure control?
Study design
Study design: A prospective cohort study.
Study burden and risks
At home, participants are asked to complete questionnaires on a variety of
topics (either on paper or through an online approach) (see table 1).
Additional measurements include a blood pressure measurement, length, weight,
waist circumference, a 12 lead ECG, carotid, cardiac and abdominal ultrasound,
blood and urine sample. Apart from the time -consuming burden of the
appointments, the questionnaires, ECG, blood pressure measurements, ultrasound
examinations and blood sampling are not associated with any considerable risk.
The general idea is that overall UHP-UCC participants benefit from all
measurements because their cardiovascular health status will be measured in
detail and the results including treatment advice will be sent to the
concerning general practitioner. Therefore, potentially (more) tailored therapy
strategy can be effectuated.
Universiteitsweg 100 100
Utrecht 3584 CG
NL
Universiteitsweg 100 100
Utrecht 3584 CG
NL
Listed location countries
Age
Inclusion criteria
• Being a participant of the Utrecht Health Project.
• Having a signed written UHP informed consent, allowing follow-up through
linkage with registries and sharing information across medical professionals.
• Indicated in UHP informed consent to be interested in participating in
further research.
• Having had blood samples stored in the UHP biobank.
Exclusion criteria
• Receiving major (cardiovascular) surgery, and/or revascularisation therapy
and/or transplantation treatment within 3 months after enrolment.
• Below the age of 40 years and above 84.
• Not willing to give written informed consent for UHP-UCC.
• Not allowing incidental findings to be reported.
If the patient gives broad consent, the patient allows to be informed about
findings that may be important for him/her. If the patient and/or his
representative refuse to agree on this, the patient will not be included.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL74683.041.20 |