HsTnT in Stable Coronary Artery Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Dr. Moritz Biener, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01954303
First received: September 26, 2013
Last updated: April 14, 2014
Last verified: April 2014

September 26, 2013
April 14, 2014
October 2013
April 2014   (final data collection date for primary outcome measure)
Cardiovascular death [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01954303 on ClinicalTrials.gov Archive Site
Recurrent Myocardial Infarction [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Recurrent coronary intervention [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
 
HsTnT in Stable Coronary Artery Disease
Elevated High-sensitivity Cardiac Troponin T Levels in Patients With Stable Coronary Artery Disease

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 (n=910) 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.

Not Provided
Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

We plan to conduct a single-centre pilot study in a cohort with clinically stable patients (n=910) of our outpatient clinic who presented 12 months after introduction of the high-sensitivity troponin T assay (june 2009) for routine workup. No patients will be excluded.

All patients with stable CAD with or without cardiovascular comorbidities will be selected and classified as "troponin positive" or "troponin negative" according to initially documented hs-cTnT value.

Coronary Artery Disease
Other: Progress of CHD
  • Troponin status
    Patients are divided into "troponin positive" (if hsTnT on first presentation is <14 ng/L) and "troponin negative" (if hsTnT on first presentation is >=14 ng/l).
    Intervention: Other: Progress of CHD
  • Progress of CHD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
910
October 2015
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients of outpatient clinic presenting 12 months after introduction of the hs-TnT test in june 2009

Exclusion Criteria:

  • none
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01954303
UHHD-BM-001
No
Dr. Moritz Biener, University Hospital Heidelberg
University Hospital Heidelberg
AstraZeneca
Not Provided
University Hospital Heidelberg
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP