Actively Recruiting
Assessment of Risk Factors for Coronary Circulatory and Microcirculatory Disorders, Comparison of Invasive and Non-Invasive Diagnostic Methods, and Evaluation of the Impact of Individualized Pharmacotherapy on Quality of Life
Led by Medical University of Bialystok · Updated on 2026-04-08
180
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether tailoring drug treatment based on detailed analysis of coronary microvascular function improves quality of life for adults with ischemia but no significant blockages in their coronary arteries. This study focuses on patients with chronic coronary syndrome who continue to experience symptoms despite standard care. It aims to compare endotype-guided pharmacotherapy with usual treatment over a three-month period to see if it better relieves symptoms and improves patient-reported angina scores. Participants will be randomly assigned to one of two groups: an intervention group receiving medication targeted to their specific coronary microvascular dysfunction type identified through invasive and non-invasive tests, or a control group receiving standard drug therapy. All participants undergo comprehensive heart function assessments, including intracoronary acetylcholine testing, measurements of coronary flow reserve and microvascular resistance with specialized equipment, and echocardiographic coronary flow velocity reserve. The control group will cross over to receive endotype-guided treatment after three months, and both groups will have follow-up evaluations at three and six months. During the study, participants will provide blood and urine samples to analyze biomarkers related to inflammation and oxidative stress. They will complete questionnaires assessing quality of life, anxiety, and functional capacity, and perform a six-minute walk test at baseline and follow-up visits. The main outcome is the change in angina symptoms measured by the Seattle Angina Questionnaire after three months. Secondary outcomes include biomarker analysis, diagnostic test accuracy, anxiety scores, and functional status. Safety and adverse events will also be monitored throughout the study period, which is expected to end in March 2028.
CONDITIONS
Brief Title
COronoary Microcirculation Analysis NETwork
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosis of chronic coronary syndrome
- Anginal symptoms greater than CCS class I or equivalent chest pain
- Myocardial ischemia confirmed by non-invasive testing
- Provided informed consent to participate in the study
You will not qualify if you...
- Significant coronary artery stenosis or fractional flow reserve below 0.8
- Kidney failure with eGFR less than 30 ml/min/1.73 m²
- Left ventricular ejection fraction below 40%
- Hypertrophic cardiomyopathy
- Acute coronary syndrome within the past 90 days
- Percutaneous coronary intervention within the past 90 days
- Previous coronary artery bypass grafting
- Anemia less than 10 g/dL or low platelet count under 100,000/µL
- Heart conduction problems preventing ST-T segment assessment
- Severe valvular heart disease
- Active cancer
- Type 1 diabetes mellitus
- Coronary artery abnormalities preventing proper assessment
- Pregnancy
- Heart failure classified as NYHA class III or higher
- Severe asthma or COPD with irreversible airflow obstruction
- Atrial fibrillation
- Second- or third-degree atrioventricular block without pacemaker
- Pre-excitation on ECG or history of certain arrhythmias without prior ablation of accessory pathway
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo invasive and non-invasive evaluation of coronary microvascular function to determine the specific coronary microvascular dysfunction endotype.
1 visit (in-person)
Duration - 3 months
Participants receive either endotype-guided pharmacotherapy tailored to their specific coronary microvascular dysfunction or standard pharmacotherapy according to current clinical practice.
1 outpatient visit at 3 months and 1 telephone follow-up call 1 month after treatment initiation (for intervention arm)
Duration - 3 months
Participants are reassessed by telephone at 6 months from baseline to evaluate quality of life, symptoms, and clinical status. Participants initially in the control group receive endotype-guided treatment after 3 months.
1 telephone visit at 6 months
Trial Site Locations
Total: 1 location
1
University Clinical Hospital, Department of Invasive Cardiology, Internal Medicine with CICU and Catheterization Laboratory-Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Kardiologii Inwazyjnej, Chorób Wewnętrznych z OIOK i Pracownią Hemodynamiki
Bialystok, Poland, 15-276
Actively Recruiting
Research Team
M
Maciej A. Poludniewski, MD, PhD
E
Emil J. Dąbrowski, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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