Effect of Beta-blockers on Coronary Flow and Resistance in Patients With ANOCA
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVZW Cardiovascular Research Center Aalst
About this trial
The goal of this clinical trial is to learn whether beta-blockers can improve coronary blood flow and reduce resistance in patients with angina and no obstructive coronary arteries (ANOCA).
The main questions it aims to answer are:
* Do beta-blockers improve coronary blood flow in patients with ANOCA? * Do beta-blockers reduce coronary microvascular resistance in these patients?
Researchers will compare a beta-blocker to a placebo to see if the medication has measurable effects on coronary circulation.
Participants will:
* Receive a beta-blocker or a placebo * Undergo specialized heart tests (such as coronary flow and resistance measurements) before and after treatment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients undergoing diagnostic coronary angiography for suspected angina pectoris who are found to have ANOCA i.e. an FFR >0.80 and no diameter stenosis >50%
Normal, TIMI 3 flow at angiography
Stable haemodynamics
Disqualifiers
Clinical signs or symptoms of congestive heart failure
Severe valvular heart disease requiring either surgical or percutaneous intervention
History of coronary artery bypass grafting
Tortuous coronary anatomy in which wire manipulation could be complex
Trial design
Design model
Parallel
Treatments tested in this trial
Saline (NaCl)
DrugIV 0.9% NaCl (5 ml)
Metoprolol Tartrate
DrugMetoprolol Tartrate (5 ml of 1 mg/ml solution for injection)
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Beta-blockerActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the absolute coronary flow 10 minutes after administration of the intervention
Absolute coronary flow will be measured using continuous intracoronary thermodilution
Time frame
10 minutes from the administration of the intervention2
Change from baseline in the absolute microvascular resistance 10 minutes after administration of the intervention
Absolute microvascular resistance will be calculated using absolute coronary flow and distal coronary pressure
Time frame
10 minutes from the administration of the intervention3
Change from baseline in the microvascular resistance reserve (MRR) 10 minutes after administration of the intervention
MRR will be calculated using absolute coronary flow, aortic pressure and distal coronary pressure
Time frame
10 minutes from the administration of the interventionSecondary outcomes
1
Change from baseline in the coronary flow reserve (CFR) 10 minutes after administration of the intervention
CFR will be calculated using absolute coronary flow
Time frame
10 minutes from the administration of the intervention2
Change from baseline in the absolute epicardial resistance 10 minutes after administration of the intervention
Absolute epicardial resistance will be calculated using absolute coronary flow, aortic pressure and distal coronary pressure
Time frame
10 minutes from the administration of the intervention3
Change from baseline in aortic pressure 10 minutes after administration of the intervention
Aortic pressure will be measured using the coronary guiding catheter
Time frame
10 minutes from the administration of the intervention4
Change from baseline in distal coronary pressure 10 minutes after administration of the intervention
Distal coronary pressure will be measured using a standard coronary pressure wire
Time frame
10 minutes from the administration of the interventionSponsors and contacts
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Source ClinicalTrials.gov