Ignite Creation Date:
2024-05-06 @ 2:02 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01954303
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2013-09-26
Brief Title:
HsTnT in Stable Coronary Artery Disease
Sponsor:
University Hospital Heidelberg
Organization:
University Hospital Heidelberg
Study Overview
Official Title:
Elevated High-sensitivity Cardiac Troponin T Levels in Patients With Stable Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Coronary artery disease CAD is one of the leading causes of morbidity and mortality worldwide Life threatening manifestations such as acute myocardial infarction AMI and sudden cardiac death are the most important causes of death in many countries Cardiac troponin is a biomarker with a high specificity for cardiac necrosis and is recommended for diagnosis of acute myocardial infarction by the Universal definition of myocardial infarction Since a new generation of high-sensitivity cardiac troponin assays has become commercially available a few years ago myocardial infarction can be detected earlier and even small AMIs that were classified as unstable angina pectoris UAP with the less sensitive assays are detectable now On the other side more patients with acute or chronic myocardial damage not due to AMI are identified now Thereby the reason for elevated troponin levels should be sought actively because high troponin levels were associated with adverse outcome - independent of the underlying pathomechanism The reasons for troponin elevations in patients with stable CAD are not clear yet Associations with extensive atherosclerosis carotid lesions and complex coronary plaques in coronary CT scans were reported Therefore patients with elevated troponin levels represent a risk population and might profit from intensified secondary prevention In this context ticagrelor might be part of a prevention strategy as currently tested in the PEGASUS trial
We plan to conduct a single-centre pilot study in a cohort with clinically stable patients of our outpatient clinic because data regarding prevalence causes and prognosis of elevated troponin values in unselected cohorts is sparse Therefore all patients n910 that presented to our outpatient clinic 12 months after introduction of the high-sensitivity troponin T assay june 2009 and were free of complaints or presented with UAP are being enrolled All patients are characterized by demographic laboratory and clinical characteristics including medication and all available imaging data exercise-ecg echocardiography stress-echocardiography computed tomography cardiac MRI and coronary angiography in order to compare baseline characteristics of troponin positive and troponin negative patients In addition the Framingham- and PROCAM-Score representing established calculators of long-term risk prediction are calculated
Prognostic endpoints are defined as severe cardiovascular events and progress of the initially diagnosed disease Those endpoints are associated with the initial hs-cTnT value and serial changes
We plan to conduct a single-centre pilot study in a cohort with clinically stable patients of our outpatient clinic because data regarding prevalence causes and prognosis of elevated troponin values in unselected cohorts is sparse Therefore all patients n910 that presented to our outpatient clinic 12 months after introduction of the high-sensitivity troponin T assay june 2009 and were free of complaints or presented with UAP are being enrolled All patients are characterized by demographic laboratory and clinical characteristics including medication and all available imaging data exercise-ecg echocardiography stress-echocardiography computed tomography cardiac MRI and coronary angiography in order to compare baseline characteristics of troponin positive and troponin negative patients In addition the Framingham- and PROCAM-Score representing established calculators of long-term risk prediction are calculated
Prognostic endpoints are defined as severe cardiovascular events and progress of the initially diagnosed disease Those endpoints are associated with the initial hs-cTnT value and serial changes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None