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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06083155
Acronym
NL-CFT
Enrollment
2000
Registered
2023-10-13
Start date
2020-10-15
Completion date
2035-10-31
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Vasospasm, Coronary Microvascular Dysfunction, Non-Obstructive Coronary Atherosclerosis

Brief summary

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_TESTCoronary Function Test

All participants are referred for a clinically indicated coronary function test

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

Sponsors

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

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Referred for clinically indicated CFT

Exclusion criteria

* Not willing to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of coronary vasomotor dysfunctionBaselineCan 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. 1. Normal CFT results 2. Vasospastic endotype (epicardial or microvascular); tested by acetylcholine provocation 3. Microvascular dysfunction endotype (decreased coronary flow reserve or increased index of microvascular resistance); tested by bolus thermodilution, optionallly with additional continuous thermodilution method 4. Mixed endotype

Secondary

MeasureTime frameDescription
Angina burdenBaseline and every year up to 5 years after baselineMeasured by Seattle Angina Questionnaire summary score, 0-100 with higher scores indicating better (functional) status.
Experienced quality of lifeBaseline and every year up to 5 years after baselineMeasured by Short Form 36, 0-100 with higher scores indicating better quality of life

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026