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
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Other: Progress of CHD

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Elevated High-sensitivity Cardiac Troponin T Levels in Patients With Stable Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Cardiovascular death [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrent Myocardial Infarction [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Recurrent coronary intervention [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 910
Study Start Date: October 2013
Estimated Study Completion Date: October 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).
Other: Progress of CHD
Progress of CHD

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr. Moritz Biener, Resident, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01954303     History of Changes
Other Study ID Numbers: UHHD-BM-001
Study First Received: September 26, 2013
Last Updated: April 14, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014