The NetherLands Registry of Invasive Coronary Vasomotor Function Testing (NL-CFT)
NL-CFT
1 other identifier
observational
2,000
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2020
CompletedFirst Submitted
Initial submission to the registry
August 23, 2023
CompletedFirst Posted
Study publicly available on registry
October 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2035
May 14, 2024
May 1, 2024
10 years
August 23, 2023
May 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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. 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
Baseline
Secondary Outcomes (2)
Angina burden
Baseline and every year up to 5 years after baseline
Experienced quality of life
Baseline and every year up to 5 years after baseline
Study Arms (2)
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
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
Interventions
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
Eligibility Criteria
All patients referred for clinically indicated CFT are eligible
You may qualify if:
- Referred for clinically indicated CFT
You may not qualify if:
- Not willing to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- UMC Utrechtcollaborator
- Catharina Ziekenhuis Eindhovencollaborator
- Maasstad Hospitalcollaborator
- VieCuri Medical Centrecollaborator
- Frisius Medisch Centrumcollaborator
- Haaglanden Medical Centrecollaborator
- Rijnstate Hospitalcollaborator
- Medisch Spectrum Twentecollaborator
- Onze Lieve Vrouwe Gasthuiscollaborator
- Tergooi Hospitalcollaborator
- Amphia Hospitalcollaborator
- Elisabeth-TweeSteden Ziekenhuiscollaborator
- Noordwest Ziekenhuisgroepcollaborator
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)collaborator
Study Sites (15)
RadboudUMC
Nijmegen, Gelderland, 6525GA, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, Netherlands
Rijnstate Hospital
Arnhem, Netherlands
Amphia Hospital
Breda, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Tergooi Hospital
Hilversum, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Maastricht UMC
Maastricht, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
Haaglanden Medisch Centrum
The Hague, Netherlands
Elisabeth-TweeSteden Hospital
Tilburg, Netherlands
UMC Utrecht
Utrecht, Netherlands
VieCuri Medisch Centrum
Venlo, Netherlands
Related Publications (1)
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 With Diagnostic Acetylcholine Provocation Dose in Vasospastic Angina. J Am Heart Assoc. 2025 Jan 21;14(2):e037913. doi: 10.1161/JAHA.124.037913. Epub 2025 Jan 16.
PMID: 39818972DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Damman
Radboud University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2023
First Posted
October 13, 2023
Study Start
October 15, 2020
Primary Completion (Estimated)
October 1, 2030
Study Completion (Estimated)
October 1, 2035
Last Updated
May 14, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share
Only participating centers that signed the joint data registry agreement can make a request for data after approval of steering committee.