Coronary Heart Disease Clinical Trial
Official title:
Feasibility of BIOchemical Urine Analysis of Adherence to Statins and Associated FACTorS in Coronary Artery Disease: The BIO-FACTS Pilot Study
Feasibilty study of biochemical urine analysis of adherence to high intensity statin therapy in outpatients with coronary artery disease
Background: Statin therapy is known to improve clinical outcomes in patients with coronary artery disease (CAD), while being highly cost-effective. However, adherence to statin therapy in real world settings is suboptimal and represents a possible target to ameliorate secondary CAD disease prevention. Previous interventional studies on statin adherence showed inconsistent results and it is widely acknowledged that a tailored adherence improvement approach adapted to patient determinants is required. However, methodology to accurately detect and characterize non-adherent patients is challenging and constitutes an important obstacle to developing such interventions. Urine analysis with liquid chromatography/mass spectrometry (LC-MS) for detection of statin intake is a promising method for objective measurement of adherence as an adjunct to subjective adherence assessment using questionnaires, which has not been applied in CAD patients in Germany. Objectives: In this pilot study (i) a feasibility testing of objective (LC-MS urine analysis) and subjective (questionnaire survey) measures of adherence to statin therapy will be performed, (ii) the prevalence of nonadherence in the target population will be determined , and (iii) instruments assessing possible factors associated with (non-)adherence (e.g. side effects, beliefs about medications, and disease-related knowledge) will be evaulated, in order to establish a methodological ground for further studies characterizing non-adherent patients. Methods: Outpatients with CAD treated in University Hospital Düsseldorf and receiving guideline-recommended atorvastatin or rosuvastatin on prescription will be included in the pilot study. Based on sample size calculation about 130 patients will be recruited. A biochemical method of objective urine measurement of statin intake by LC-MS will be combined with a preselected set of questionnaires on adherence behavior and associated factors. Clinical characteristics will be obtained from patient records. A sub-sample of the study population will be invited to participate in the interview for the evaluation of the questionnaire survey. Outlook: Based on the results of the pilot study, an adequately powered study to characterize non-adherent patients and identify patterns of non-adherence will be conducted. The results will be used for the development of a complex tailored intervention for non-adherent patients in Germany. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
| Completed |
NCT05088291 -
Application of a New X-ray Protective Device in Coronary Interventional Therapy
|
||
| Completed |
NCT03076801 -
Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?
|
N/A | |
| Completed |
NCT04584645 -
A Digital Flu Intervention for People With Cardiovascular Conditions
|
N/A | |
| Not yet recruiting |
NCT04995159 -
Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System
|
N/A | |
| Recruiting |
NCT02967718 -
Innovation Research of Differentiation and Treatment Methods Based on CHD Phlegm and Blood Stasis Syndrome
|
N/A | |
| Completed |
NCT02888652 -
Study on the Registration of Coronary Heart Disease Patients Undergoing PCI
|
||
| Terminated |
NCT02045134 -
Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery
|
N/A | |
| Completed |
NCT02163044 -
The Hellenic Postprandial Lipemia Study (HPLS)
|
||
| Active, not recruiting |
NCT02244853 -
Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease
|
N/A | |
| Completed |
NCT01920009 -
Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines
|
N/A | |
| Completed |
NCT01826552 -
Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent
|
Phase 4 | |
| Terminated |
NCT01906957 -
Cognition and Exercise Training
|
N/A | |
| Completed |
NCT02440893 -
Understanding the Effect of Metformin on Corus CAD (or ASGES)
|
||
| Completed |
NCT02753829 -
Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease
|
N/A | |
| Recruiting |
NCT01689688 -
Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography
|
N/A | |
| Completed |
NCT01779401 -
Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients
|
N/A | |
| Recruiting |
NCT01456364 -
Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing
|
Phase 4 | |
| Recruiting |
NCT01462799 -
COR-PRIM: Problem-based Learning (PBL) After Coronary Heart Disease (CHD) - Long-term Evaluation in Primary Care of Self-care
|
N/A | |
| Completed |
NCT01428947 -
Does Coronary Angiography Cause Cognitive Dysfunction?
|
N/A |