The NetherLands Registry of Invasive Coronary Vasomotor Function Testing (NL-CFT) (NL-CFT)

The goal of this registry is to collect data on patients referred for clinically indicated coronary vasomotor function test (CFT) and answer different questions on prevalence, safety and outcomes. The registry is observational. Patients receive yearly online questionnaires on their anginal complaints for 5 years after their CFT.

Study Overview

• Status: Enrolling by invitation
• Conditions: Coronary Vasospasm; Coronary Microvascular Dysfunction; Non-Obstructive Coronary Atherosclerosis
• Intervention / Treatment: Diagnostic test: Coronary Function Test; Other: Patient questionnaires

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Amsterdam UMC
  • Amsterdam, Netherlands
    • Onze Lieve Vrouwe Gasthuis (OLVG)
  • Arnhem, Netherlands
    • Rijnstate Hospital
  • Breda, Netherlands
    • Amphia Hospital
  • Den Haag, Netherlands
    • Haaglanden Medisch Centrum
  • Eindhoven, Netherlands
    • Catharina Ziekenhuis
  • Enschede, Netherlands
    • Medisch Spectrum Twente
  • Hilversum, Netherlands
    • Tergooi Hospital
  • Leeuwarden, Netherlands
    • Medisch Centrum Leeuwarden
  • Maastricht, Netherlands
    • Maastricht UMC
  • Rotterdam, Netherlands
    • Maasstad Ziekenhuis
  • Tilburg, Netherlands
    • Elisabeth-TweeSteden Hospital
  • Utrecht, Netherlands
    • UMC Utrecht
  • Venlo, Netherlands
    • VieCuri Medisch Centrum
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525GA
      • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients referred for clinically indicated CFT are eligible

Description

Inclusion Criteria:

• Referred for clinically indicated CFT

Exclusion Criteria:

• Not willing to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal CFT results: no coronary vasomotor dysfunction; Collection of data on anginal complaints, use of medication and major adverse cardiac events (MACE) by means of online patient questionnaires	Diagnostic test: Coronary Function Test; All participants are referred for a clinically indicated coronary function test; Other: Patient questionnaires; All participants that consent will receive yearly followup questionnaires for 5 years after their initial consent
Abnormal CFT results: coronary vasomotor dysfunction; Comparison of patient reported outcomes of different endotype groups Collection of data on anginal complaints, use of medication and MACE by means of online patient questionnaires	Diagnostic test: Coronary Function Test; All participants are referred for a clinically indicated coronary function test; Other: Patient questionnaires; All participants that consent will receive yearly followup questionnaires for 5 years after their initial consent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of coronary vasomotor dysfunction	Can be handled as dichotomous outcome with normal vs abnormal coronary function test (CFT) results. Alternatively, can also be handled as categorical outcome with the following categories.; Normal CFT results; Vasospastic endotype (epicardial or microvascular); tested by acetylcholine provocation; Microvascular dysfunction endotype (decreased coronary flow reserve or increased index of microvascular resistance); tested by bolus thermodilution, optionallly with additional continuous thermodilution method; Mixed endotype	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angina burden	Measured by Seattle Angina Questionnaire summary score, 0-100 with higher scores indicating better (functional) status.	Baseline and every year up to 5 years after baseline
Experienced quality of life	Measured by Short Form 36, 0-100 with higher scores indicating better quality of life	Baseline and every year up to 5 years after baseline

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: UMC Utrecht; Catharina Ziekenhuis Eindhoven; Noordwest Ziekenhuisgroep; Medical Centre Leeuwarden; Elisabeth-TweeSteden Ziekenhuis; Rijnstate Hospital; VieCuri Medical Centre; Maasstad Hospital; Onze Lieve Vrouwe Gasthuis; Medisch Spectrum Twente; Amphia Hospital; Tergooi Hospital; Haaglanden Medical Centre; Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
• Investigators: Principal Investigator: Peter Damman, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2035

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis; Coronary Vasospasm
• Other Study ID Numbers: 79233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only participating centers that signed the joint data registry agreement can make a request for data after approval of steering committee.

Drug and device information, study documents

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