Objective of this study is to compare the diagnostic yield of the Early Diagnosis Strategy to usual care, in terms of detection and subsequent treatment of previously unrecognized CAD, AF and HF.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of newly detected cases with CVDs (heart failure, atrial
fibrillation or coronary artery disease) in both arms, and the subsequent
targeted therapies these new cases received.
Secondary outcome
1. the added diagnostic value of family history taking, and, in women,
reproductive history
2. the added diagnostic value of biomarkers other than NT-proBNP, i.e.
high-sensitive troponine (hs-Tn), growth differentiation factor 15
(GDF-15),ST-2?
3. the cost-effectiveness of the Early Diagnosis Strategy compared to usual
care
Background summary
The early stages of cardiovascular disease (CVD) generally cause non-specific
or atypical symptoms that patients often do not spontaneously mention to their
general practitioner. This makes that new onset CVD is easily missed. A more
proactive diagnostic strategy has the potential to uncover these frequently
missed early stages, thus creating an opportunity for early intervention that
may prevent progression into chronic CVD or devastating acute cardiovascular
events. This is of particular importance for cardiovascular diseases with
evidence-based therapies known to improve prognosis, such as coronary artery
disease (CAD), atrial fibrillation (AF) and heart failure (HF).
Previous studies have shown that patients with type 2 diabetes (T2D) or chronic
obstructive lung disease (COPD) are at highly increased risk of developing CVD,
and that 20-65% of these patients have 'concealed' CVD. In the current study,
we will test a newly developed Early Diagnostic Strategy, aimed at these high
risk patients and blended in with the primary care disease management programs
these patients routinely participate in.
Study objective
Objective of this study is to compare the diagnostic yield of the Early
Diagnosis Strategy to usual care, in terms of detection and subsequent
treatment of previously unrecognized CAD, AF and HF.
Study design
A cluster randomized diagnostic trial with 40 primary care practices at the
unit of randomization.
Intervention
The two stage Early Diagnostic Strategy, consisting of the Early Diagnosis
Questionnaire (stage 1) to be filled in at home prior to the next routine
visit, followed if necessary by physical examination of legs, heart and lungs,
electrocardiography and BNP-measurement (stage 2).
Study burden and risks
As our new Early Diagnosis Strategy is to be blended in with the
well-established primary care disease-management programs for COPD and T2D, the
burden associated with participation will be relatively low. No extra visits
will be required; patients will be asked to fill out the questionnaires before
their regular visits. Our strategy depends solely on non-invasive and minimally
invasive (blood taking), standard diagnostic procedures. In case of suspected
CVD, standard diagnostic procedures will be applied according to
(inter)national guidelines on CVDs. There is a potential benefit associated
with participation, as we aim to uncover early stage CVD that might not have
been detected otherwise, and for which early treatment is prognostically
beneficial. Minors and persons with severe cognitive impairment or who are not
proficient in Dutch will not be included.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
1. Currently enrolled in a primary care (chronic) disease management program
for either COPD or T2D
2. Age 18 years or over
3. Willing to sign informed consent
Exclusion criteria
1. Not proficient in Dutch or having severe cognitive impairment (i.e. not able
to understand and correctly fill in the questionnaire)
2. Having a triple diagnosis of HF, CAD and AF. Confirmed with echocardiography
in case of HF, with coronary angiography, exercise-test, stress-echo, stress
MRI, SPECT-CT/MIBI or calcium score > 100 on CT-scan in case of CAD, with
electrocardiography in case of AF.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL65798.041.18 |
OMON | NL-OMON24396 |