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

Coronary Microvascular Dysfunction Clinical Trial

— NL-CFT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06083155
• Other study ID #: 79233
• Status: Enrolling by invitation
• Start date: October 15, 2020
• Est. completion date: October 2035

Study information

• Verified date: May 2024
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: October 2035
• Est. primary completion date: October 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Referred for clinically indicated CFT

Exclusion Criteria:

• Not willing to provide informed consent

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Microvascular Dysfunction
• Coronary Vasospasm
• Myocardial Ischemia
• Non-Obstructive Coronary Atherosclerosis

Intervention

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

Locations

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

Sponsors (15)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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