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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05313919
Other study ID # 304/KBL/OIL2019
Secondary ID PL-2020-01
Status Recruiting
Phase
First received
Last updated
Start date July 24, 2020
Est. completion date June 30, 2023

Study information

Verified date March 2022
Source John Paul II Hospital, Krakow
Contact Bartlomiej Guzik, MD, PhD
Phone +48 614 35 01
Email b.guzik@uj.edu.pl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients with chronic coronary syndromes (CCS) diagnosed without significant lesions in invasive coronary angiography (ischemia non-obstructive coronary artery disease - INOCA) represent approximately 50% of all patients with CCS. Results of FAME study clearly showed that evaluation of coronary circulation should not be accomplished only with visual assessment in resting conditions. Current European Society of Cardiology Guidelines of diagnosis and treatment of CCS published in 2019 emphasize the necessity of performing complex coronary physiology assessment. Invasive physiological measurements and vasoreactivity provocative tests emerged as key tools to differentiate between vasospastic angina, microcirculatory angina, overlap of both conditions or non-cardiac disease. According to contemporary literature, identification of heterogeneity of patients with INOCA is crucial for determination of adequate treatment. An appropriate pharmacotherapy has a potential to improve outcomes including grade of angina, quality of life, exertional tolerance and most important - MACCE (major adverse cardiac and cardiovascular events) free survival. However, there is a lack of evidence on each of the subtypes of INOCA especially in those with signs and symptoms of vasospasm in provocative test but without visual spasm in epicardial vessels.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date June 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: 1. Diagnosed chronic coronary syndrome CCS = 2. 2. Evidence of myocardial ischemia (positive result of non-invasive stress test). 3. Informed consent. 4. Age at least 18 years. Exclusion Criteria:

Study Design


Intervention

Diagnostic Test:
Comprehensive functional diagnostics of coronary circulation
Comprehensive functional diagnostics of coronary circulation in patients with INOCA (ischemia and no obstructive coronary arteries) including: echocardiography with assessment of diastolic function flow-mediated dilation of brachial artery coronary angiography functional coronary assessment (RFR, FFR, IMR, CFR, dp/dt, Tau) provocative test with acetylcholine (registration of symptoms, ECG and angiographic spasm) laboratory tests (full blood count, serum creatinine level, eGFR, lipidogram, serum CRP/hsCRP level, serum NT-proBNP level) serum level of inflammatory cytokines and chemokines

Locations

Country Name City State
Poland Department of Interventional Cardiology, John Paul II Hospital, Krakow, Poland, Institute Of Cardiology, Jagiellonian University Medical College Krakow Lesser Poland

Sponsors (2)

Lead Sponsor Collaborator
Bartlomiej Guzik Abbott

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cytokines (serum levels) baseline
Primary Diastolic Disfunction parameters in ECHO baseline, 12- and 24-month follow-up
Secondary MACCE occurrence baseline, 12- and 24-month observation
Secondary Hospitalization any baseline, 12- and 24-month observation
Secondary symptoms intensity and quality of life (questionnaires) baseline, 12- and 24-month observation
Secondary FMD baseline, 12- and 24-month observation
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