Coronary Microcirculatory Disease and Inflammation in Patients With Chronic Coronary Syndrome and no Significant Coronary Artery Stenosis

NCT05313919 | Unknown

• 2 other identifiers: 304/KBL/OIL2019PL-2020-01
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Ischemia and No Obstructive Coronary Arteries; Ischemic Heart Disease; Microvascular Angina; Vasospastic Angina

Keywords

coronary artery disease; ischemia and no obstructive coronary arteries; ischemic heart disease; microvascular angina; vasospastic angina; coronary microvascular dysfunction; coronary microcirculation; endothelial dysfunction

Outcome Measures

Primary Outcomes (2)

• Cytokines (serum levels)

  baseline

• Diastolic Disfunction parameters in ECHO

  baseline, 12- and 24-month follow-up

Secondary Outcomes (4)

• MACCE occurrence

  baseline, 12- and 24-month observation

• Hospitalization any

  baseline, 12- and 24-month observation

• symptoms intensity and quality of life (questionnaires)

  baseline, 12- and 24-month observation

• FMD

  baseline, 12- and 24-month observation

Study Arms (4)

1. Coronary microcirculatory disease

Diagnostic Test: Comprehensive functional diagnostics of coronary circulation

2. Epicardial vasospastic angina

Diagnostic Test: Comprehensive functional diagnostics of coronary circulation

3. Microvessel vasospastic angina

Diagnostic Test: Comprehensive functional diagnostics of coronary circulation

4. Non-cardiac disorder

Diagnostic Test: Comprehensive functional diagnostics of coronary circulation

Interventions

Comprehensive functional diagnostics of coronary circulation DIAGNOSTIC_TEST

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

1. Coronary microcirculatory disease; 2. Epicardial vasospastic angina; 3. Microvessel vasospastic angina; 4. Non-cardiac disorder

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic chronic coronary syndrome and no significant lesions in epicardial coronary arteries in angiography.

You may qualify if:

• Diagnosed chronic coronary syndrome CCS ≥ 2.
• Evidence of myocardial ischemia (positive result of non-invasive stress test).
• Informed consent.
• Age at least 18 years.

Sponsors & Collaborators

• Bartlomiej Guzik: lead
• Abbott: collaborator

Study Sites (1)

Department of Interventional Cardiology, John Paul II Hospital, Krakow, Poland, Institute Of Cardiology, Jagiellonian University Medical College

Krakow, Lesser Poland Voivodeship, 31-202, Poland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Ischemia; Myocardial Ischemia; Microvascular Angina; Angina Pectoris, Variant

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Angina Pectoris; Angina, Unstable; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Bartłomiej Guzik, MD, PhD

  John Paul II Hospital, Krakow, Poland

  PRINCIPAL INVESTIGATOR

• Jacek Legutko, MD, PhD, Professor

  John Paul II Hospital, Krakow, Poland

  STUDY DIRECTOR

Central Study Contacts

Bartłomiej Guzik, MD, PhD

CONTACT

+48 614 35 01; b.guzik@uj.edu.pl

Piotr Szolc, MD

CONTACT

+48 614 35 01; piotr.szolc4@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 6, 2022
• Study Start: July 24, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

PL (1)