To find the predictors of ventricular arrhythmias in patients receiving an ICD
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint of the study:
Approppriate ICD therapy
Secondary outcome
Secondary endpoints:
Mortality
Complications
Spurious shocks
Background summary
Survivors of sudden cardiac death have got a higher risk of developing
ventricular arrhythmias in the future. The implantation of an ICD reduces risk
of sudden cardiac death. Patients with a cardiomyopathy or survivors of a
myocardial infarction with a reduced left ventricular function have also got an
increased risk of developing ventricular arrhtythmias. These patients have got
a better prognosis when they receive an ICD.
Patients receive an ICD according to the guidelines of the NVVC. Many patients
who receive an ICD never receive appropriate ICD therapy.
It is still not possible to accurately predict which patients will benefit most
from an ICD. The implantation of an ICD carries the risk of developing
complications (haemorrhage, infections, pneumothorax, inappropriate shocks).
The ICD works on batteries with a life expectancy of approximately 7 years.
When the battery approaches the end of life, the ICD has to be replaced and the
patient has to undergo another operation. Besides the risk of complications the
implantation of an ICD carries high costs. Therefore effort should be made to
be able to predict more accurately which patients will benefit most from an
ICD.
Study objective
To find the predictors of ventricular arrhythmias in patients receiving an ICD
Study design
TICS is a single centre prospective cohort study.
Information from the medical report will be used for the Twente ICD cohort
study.
Extra information is collected to determine the predictors of ventricular
tachycardia/ ventricular fibrillation in patients with an ICD:
-a late enhancement MRI will be performed for the assessment of scar
distribution. Since the ejection fraction can be assessed with MRI, an MRI can
be made in stead of SPECT myocardial perfusion imaging
-laboratory measurements (if not known): NT-proBNP, glyc Hb
-EDTA blood sample for future DNA-research
-MTWA exercise test
-depression questionnaire: HADS (before ICD-implantation and 1 and 2 years
after ICD implantation)
-physical activity questionnaire: PASE (physical activity scale for the
elderly) (before ICD-implantation and 1 and 2 years after ICD implantation)
-quality of life questionnaire : SF 36 (before ICD-implantation and 1 and 2
years after ICD implantation)
-coping strategy questionnaire: UCL (Utrechtse copinglijst)
The questionnaires have to be filled in at baseline, at 6, 12, 18 and 24 months.
The follow up will be 2 years. In these 2 years complications, appropriate ICD
therapy, spurious shocks en changes in medication will be recorded. After these
two years analyses will be made to see if there are significant predictors of
sudden cardiac death.
Study burden and risks
Patients will undergo a few test before the implatation of the ICD:
- a late enhancement MRI
- MTWA exercise test
Blood from the patients will be collected:
- for laboratory measurements (if not known): NT-proBNP, glyc Hb. CRP every six
months
- EDTA blood sample for future DNA-research
-Questionnaires have to be filled in by the patients at baseline, at 6, 12, 18
and 24 months:
- depression questionnaire: HADS (before ICD-implantation and 1 and 2 years
after ICD implantation)
- physical activity questionnaire: PASE (physical activity scale for the
elderly) (before ICD-implantation and 1 and 2 years after ICD implantation)
- quality of life questionnaire : SF 36 (before ICD-implantation and 1 and 2
years after ICD implantation)
- coping strategy questionnaire: UCL (Utrechtse copinglijst)
Van Lochemstraat 182 Enschede
7511 PL
NL
Van Lochemstraat 182 Enschede
7511 PL
NL
Listed location countries
Age
Inclusion criteria
-indication for and implantation of an ICD according to the guidelines of the Dutch Cardiology Society NVVC and European Society of Cardiology
-age >= 18 years
-signed informed consent
Exclusion criteria
-age < 18 years
-inability to receive informed consent
Exclusion criteria for the MRI
-claustrophobia
-pacemakers or ICD already implanted
-metal clips in the body
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 | NL13939.044.06 |