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Enrolling by invitation NCT06083155

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

— Observational Coronary Vasospasm Coronary Microvascular Dysfunction Non-Obstructive Coronary Atherosclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Coronary Function Test, Patient questionnaires.
Who it may be relevant to
Registry conditions: Coronary Vasospasm, Coronary Microvascular Dysfunction, Non-Obstructive Coronary Atherosclerosis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Prevalence of coronary vasomotor dysfunction [Time frame: Baseline]
Secondary outcome measures (2)
  • Angina burden [Time frame: Baseline and every year up to 5 years after baseline]
  • Experienced quality of life [Time frame: Baseline and every year up to 5 years after baseline]

Eligibility criteria

Inclusion criteria

  • Referred for clinically indicated CFT

Exclusion criteria

  • Not willing to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Netherlands · 15 centers
  • RadboudUMC — Nijmegen
  • Amsterdam UMC — Amsterdam
  • Onze Lieve Vrouwe Gasthuis (OLVG) — Amsterdam
  • Rijnstate Hospital — Arnhem
  • Amphia Hospital — Breda
  • Catharina Ziekenhuis — Eindhoven
  • Medisch Spectrum Twente — Enschede
  • Tergooi Hospital — Hilversum
  • … and 7 more centers

Publications

  • Crooijmans C, Jansen TPJ, Meeder JG, Paradies V, de Vos AMJ, Woudstra P, Vossenberg TNE, van de Hoef TP, Vos NS, Olde Bijvank EGM, van den Oord SCH, Winkler P, Meuwissen M, Widdershoven JWMG, Arkenbout EK, Stoel MG, Appelman Y, Beijk MAM, Cetinyurek-Yavuz A, den Ruijter HM, Elias-Smale SE, van Royen N, Dimitriu-Leen AC, Damman P; for NL-CFT. Angina Severity and Symptom Improvement Are Associated W PMID 39818972

Identifiers

NCT: NCT06083155 · 79233

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗