EUROpean Coronary microCirculatory Resistance and Absolute Flow Trial

NCT04598308 | Unknown DMC

• 1 other identifier: NL74650.100.20
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: coronary microvascular disease is a relatively 'new' entity within the field of cardiology. The investigators are able to investigate the microcirculation by measurements performed in the catheterization laboratory. But even though measurements are performed on a daily basis, a lot of questions regarding microvascular disease remain. The rationale of this registry is to get an overview of patients and measurement values in daily routine practice. Objective and main endpoint: No previous registries have been set-up where coronary blood flow and resistance was systematically stored. Therefore the analyses will be mainly descriptive. The objective is to acquire a better insight in the indications and use of this technique in everyday practice , its consequences for clinical decision making, and to enable interventionalists to exchange mutual knowledge about this specific methodology and about the coronary microcirculation in general. Study design: prospective registry Study population: All patients who underwent coronary angiography with or without coronary intervention for any reason and if an indication for the foreseen intracoronary physiologic measurements is present according to the discretion of the operator. Intervention (if applicable): none, only usage of measurement data. The only 'intervention' for all patients is a questionnaire.

Conditions

Microvascular Angina; Microvascular Coronary Artery Disease; Coronary Vasospasm; Microvascular Resistance

Keywords

coronary microvascular disease; ANOCA; epicardial spasm

Outcome Measures

Primary Outcomes (1)

• clinical treatment assessment

  change in clinical decision making after invasive assessment of the microcirculation

  1 year

Secondary Outcomes (1)

• IMR and resistance measurement

  2 years

Study Arms (1)

patients undergoing invasive assessment of the microcirculation

All patients are eligible for participation in this registry if they are undergoing coronary angiography with or without coronary intervention for any reason and if an indication for the foreseen intracoronary physiologic measurements is present according to the discretion of the investigating operator. There are no specific exclusion criteria other than contraindications for physiologic measurements in general.

Diagnostic Test: absolute flow and resistance measurements

Interventions

absolute flow and resistance measurements DIAGNOSTIC_TEST

This registry only collects all measurement data from normal/routine physiologic assessment in the cathlab. These measurements are performed on a daily basis Short description of the procedure Coronary angiography, PCI (if indicated), and physiologic measurements are performed completely according to normal routine. Physiologic measurements may include FFR, NHPR, IMR, CFR, absolute flow (Q) and microcirculatory resistance (Rmicro or MRR) measurement. Intention to measure Q and Rmicro are mandatory to be included in this registry. Use of drugs either during or after the procedure should also exactly identical to normal routine.

patients undergoing invasive assessment of the microcirculation

Eligibility Criteria

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

Study Population

see above

You may qualify if:

• All patients are eligible for participation in this registry if they are undergoing coronary angiography with or without coronary intervention for any reason and if an indication for the foreseen intracoronary physiologic measurements is present according to the discretion of the investigating operator.
• \>18 and \<90 years of age
• able to give informed consent

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead
• Onze Lieve Vrouwziekenhuis Aalst: collaborator

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623EJ, Netherlands

RECRUITING

MeSH Terms

Conditions

Microvascular Angina; Coronary Vasospasm

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease

Central Study Contacts

Danielle Keulards, MD

CONTACT

0031402397000; danielle.keulards@catharinaziekenhuis.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 22, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

NL (1)