BIOchemical Urine Analysis of Adherence to Statins and Associated FACTorS in Coronary Artery Disease

NCT05814692 | Unknown

• 1 other identifier: BIO-FACTS
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Feasibilty study of biochemical urine analysis of adherence to high intensity statin therapy in outpatients with coronary artery disease

Conditions

Coronary Heart Disease

Keywords

coronary artery disease; statin; atorvastatin; Rosuvastatin; adherence; biochemical urine testing of adherebnce

Outcome Measures

Primary Outcomes (6)

• Recrutiment Rate

  Recruitment will be assessed by proportion of eligible patients (in %) that agree to participate in the study

  through study completion, approximately 1 year

• Rate of participating patients (in %) from whom a urine sample can be obtained that is suitable for detection analysis of atorvastatin or rosuvastatin by liquid chromatography/mass spectrometr

  Rate of participating patients (in %) from whom a urine sample can be obtained that is suitable for detection analysis of atorvastatin or rosuvastatin by liquid chromatography/mass spectrometry

  through study completion, approximately 1 year

• Rate of urine samples (in %) from which a valid result of liquid chromatography/mass spectrometry analysis for detection of atorvastatin or rosuvastatin can be obtained.

  Rate of urine samples (in %) from which a valid result of liquid chromatography/mass spectrometry analysis for detection of atorvastatin or rosuvastatin can be obtained.

  through study completion, approximately 1 year

• Average time (in minutes) that is needed by the study personnel to inform the patient about the study, receive written informed consent, hand out and retrieve the study questionnaire, and obtain a urine sample from the participant.

  Average time (in minutes) that is needed by the study personnel to inform the patient about the study, receive written informed consent, hand out and retrieve the study questionnaire, and obtain a urine sample from the participant.

  through study completion, approximately 1 year

• Average time (in minutes) that is needed by the participants to complete the study questionnaire

  Average time (in minutes) that is needed by the participants to complete the study questionnaire

  through study completion, approximately 1 year

• Rate of questions (in %) in the study questionnaire that are completely answered by participants

  Rate of questions (in %) in the study questionnaire that are completely answered by participants

  through study completion, approximately 1 year

Secondary Outcomes (12)

• Rate of patients (in %) in whom atorvastatin or rosuvastatin is detected by liquid chromatography/mass spectrometry analysis of a urine sample

  through study completion, approximately 1 year

• Rate of patients (in %) who report good adherence atorvastatin or rosuvastatin assessed by Medical Adherence Report Scale (MARS-D)

  through study completion, approximately 1 year

• Rate of patients (in %) from whom information on concomitant medication other than atorvastatin or rosuvastatin can be obtained from medical records

  through study completion, approximately 1 year

• Rate of patients (in %) from whom information on comorbidities (i.e., cerebrovascular disease, peripheral artery disease, arterial hypertension, and heart failure, or other comorbidities) can be obtained from medical records

  through study completion, approximately 1 year

• Rate of patients (in %) from whom socio-demographic information (i.e., level of education and income) can be obtained by the study questionnaire.

  through study completion, approximately 1 year

Interventions

blood and urine samples DIAGNOSTIC_TEST

blood and urine samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with coronary artery disease and prescription of atorvastatin or rosuvastin

You may qualify if:

• patients with coronary artery disease
• prescription of atorvastatin or rosuvastatin

You may not qualify if:

• \< 18 years
• impairment (e.g. dementia)
• language barrier (German)
• end-stage kidney disease with hemodialysis

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

prospectively defined blood and urine sampling protocol

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Malte Kelm, Prof.

  Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf

  STUDY CHAIR

Central Study Contacts

Maximillian Brockmeyer, MD

CONTACT

: +492118118800; maximilian.brockmeyer@med.uni-duesseldorf.de

Lisa Dannenberg, MD

CONTACT

+49211811800; ctu@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 18, 2023
• Study Start: September 14, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)