EUROpean Coronary microCirculatory Resistance and Absolute Flow Trial (EURO-ccraft)

EUROpean Coronary microCirculatory Resistance and Absolute Flow Trial: An European Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Vasospasm; Microvascular Angina; Microvascular Coronary Artery Disease; Microvascular Resistance
• Intervention / Treatment: Diagnostic test: absolute flow and resistance measurements

Detailed Description

This registry only collects all measurement data from normal/routine physiologic assessment in the cathlab. These measurements are performed on a daily basis. The following paragraph will explain these routine measurements briefly.

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.

If there is failure to measure Q and/or Rmicro , it should be carefully noted including the reason for failure.

Coronary physiologic measurements may be performed either prior or after PCI, if applicable. If they are performed before PCI, it is recommended (according to Good Clinical Practice) but not absolutely mandatory to repeat these measurements also after PCI.

As said, the invasive procedure itself, including all measurements, should be performed completely according to clinical routine. Use of drugs either during or after the procedure should also exactly identical to normal routine.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Danielle Keulards, MD; Phone Number: 0031402397000; Email: danielle.keulards@catharinaziekenhuis.nl

Study Locations

• Netherlands
  • Brabant
    • Eindhoven, Brabant, Netherlands, 5623EJ
      • Recruiting
      • Catharina hospital
      • Contact: Nico Pijls, MD, PhD; Phone Number: 0402397000; Email: nico.pijls@catharinaziekenhuis.nl
      • Contact: Danielle Keulards, MD; Phone Number: 0402397000; Email: danielle.keulards@catharinaziekenhuis.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

see above

Description

Inclusion criteria:

• 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

Exclusion criteria:

- There are no specific exclusion criteria other than contraindications for physiologic measurements in general.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical treatment assessment	change in clinical decision making after invasive assessment of the microcirculation	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IMR and resistance measurement	comparison between IMR and microvascular R measurements in WU	2 years

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven
• Collaborators: Onze Lieve Vrouwziekenhuis Aalst

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: ANOCA; coronary microvascular disease; epicardial spasm
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Angina Pectoris; Coronary Artery Disease; Microvascular Angina; Coronary Vasospasm
• Other Study ID Numbers: NL74650.100.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No