To test the hypothesis that patients with STEMI (i.e., severe form of acute coronary syndrome) have a higher prevalence of factor V Leiden and prothrombin G20210A mutation as compared to patients with NSTEMI or uAP (less severe forms of acute…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Prevalence of factor V Leiden or Prothrombin G20210A in STEMI as compared to
NSTEMI/uAP patients.
Secondary outcome
Hemorrhagic complications during the index hospitalization in patients with
versus without factor V Leiden or prothrombin G20210A mutations.
Background summary
Coronary heart disease is generally divided in stable and unstable coronary
heart disease. The latter form, also called acute coronary syndrome, which is
triggered by atherosclerotic plaque rupture and subsequent thrombus formation
requires urgent treatment and hospitalization. Thrombus formation is a process
of platelets aggregation followed by coagulation activation, which stabilizes
the thrombus. Thrombotic burden differs across the various forms of acute
coronary syndrome, that is, ST-segment elevation myocardial infarction (STEMI),
non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina
pectoris (uAP). Whether common coagulation defects predisposing to
hypercoagulable state such as the presence of factor V Leiden (prevalence ~5%
in the general population) or prothrombin G20210A mutation (prevalence ~3% in
the general population) are associated with the severity of myocardial
infarction has yet to be investigated.
Study objective
To test the hypothesis that patients with STEMI (i.e., severe form of acute
coronary syndrome) have a higher prevalence of factor V Leiden and prothrombin
G20210A mutation as compared to patients with NSTEMI or uAP (less severe forms
of acute coronary syndrome).
Study design
Non-randomized observational case-control study.
Study burden and risks
STEMI patients will be selected from an ongoing (i.e., PUPular Genetics) trial
without additional burden for the participants. All these participants already
gave consent for DNA storage and future DNA analysis. These individuals will
not be contacted for this analysis.
NSTEMI/uAP patients will be prospectively enrolled after written informed
consent is obtained. A single blood sample in this group will be obtained from
an already established vascular access for routine clinical care. Given that no
additional venipuncture solely for this study is involved we believe there are
no venipuncture related risks associated with this study. No additional
contacts or follow-up is required.
Laan van Nieuw Oost-Indie 334
Den Haag 2509 AE
NL
Laan van Nieuw Oost-Indie 334
Den Haag 2509 AE
NL
Listed location countries
Age
Inclusion criteria
Patients with unstable angina or non-ST-segment elevation myocardial infarction.
Age above 18 years;ST-segment elevation myocardial infarction (STEMI) patients for comparison will be selected from an existing dataset of ongoing trial (i.e., POPular Genetics).
Exclusion criteria
Patients who are unable or unwilling to give informed consent (e.g., due to metal illnesses or inability to understand Dutch language).
Individuals younger than 18 years of age.
Patients with previous ST-segment elevation myocardial infarction (STEMI)
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 | NL54511.100.15 |