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OpenTrials
Enrolling by Invitation

NCT Number: NCT06083155

The NetherLands Registry of Invasive Coronary Vasomotor Function Testing (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.

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Key information

Conditions

Coronary Vasospasm Cardiovascular Diseases Coronary Disease Coronary Microvascular Dysfunction Heart Diseases Myocardial Ischemia Non-Obstructive Coronary Atherosclerosis Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

RadboudUMC, Nijmegen, Gelderland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Referred for clinically indicated CFT

Exclusion criteria

  • Not willing to provide informed consent

Treatment and study plan

Coronary Function Test

Diagnostic Test

All participants are referred for a clinically indicated coronary function test

Patient questionnaires

Other

All participants that consent will receive yearly followup questionnaires for 5 years after their initial consent

Primary outcomes

  1. Prevalence of coronary vasomotor dysfunction

    Time frame: Baseline

    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

Secondary outcomes

  1. Angina burden

    Time frame: Baseline and every year up to 5 years after baseline

    Measured by Seattle Angina Questionnaire summary score, 0-100 with higher scores indicating better (functional) status.

  2. Experienced quality of life

    Time frame: Baseline and every year up to 5 years after baseline

    Measured by Short Form 36, 0-100 with higher scores indicating better quality of life

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Amphia Hospital
  • Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
  • Catharina Ziekenhuis Eindhoven
  • Elisabeth-TweeSteden Ziekenhuis
  • Frisius Medisch Centrum
  • Haaglanden Medical Centre
  • Maasstad Hospital
  • Medisch Spectrum Twente
  • Noordwest Ziekenhuisgroep
  • Onze Lieve Vrouwe Gasthuis
  • Rijnstate Hospital
  • Tergooi Hospital
  • UMC Utrecht
  • VieCuri Medical Centre

Registry information

Acronym: NL-CFT

Important dates

Study start
2020
Primary completion
2030
Study completion
2035
First posted
Oct 13, 2023
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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