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

• Conditions: Coronary Vasospasm; Coronary Microvascular Dysfunction; Non-Obstructive Coronary Atherosclerosis
• Interventions: Diagnostic Test: Coronary Function Test; Other: Patient questionnaires

• Registration Number: NCT06083155
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-15
• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-14
• Primary Completion: 2030-10
• Study Completion: 2035-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Referred for clinically indicated CFT

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Exclusion Criteria

• Not willing to provide informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal CFT results: no coronary vasomotor dysfunction	Coronary Function Test	Collection of data on anginal complaints, use of medication and major adverse cardiac events (MACE) by means of online patient questionnaires
Normal CFT results: no coronary vasomotor dysfunction	Patient questionnaires	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	Coronary Function Test	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
Abnormal CFT results: coronary vasomotor dysfunction	Patient questionnaires	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

Primary Outcome Measures

Name	Time	Method
Prevalence of coronary vasomotor dysfunction	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.; 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 Outcome Measures

Name	Time	Method
Angina burden	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.
Experienced quality of life	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

Trial Locations

Locations (15)

Tergooi Hospital; 🇳🇱 Hilversum, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

RadboudUMC; 🇳🇱 Nijmegen, Gelderland, Netherlands

Onze Lieve Vrouwe Gasthuis (OLVG); 🇳🇱 Amsterdam, Netherlands

Haaglanden Medisch Centrum; 🇳🇱 Den Haag, Netherlands

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

Amphia Hospital; 🇳🇱 Breda, Netherlands

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Netherlands

Maasstad Ziekenhuis; 🇳🇱 Rotterdam, Netherlands

Maastricht UMC; 🇳🇱 Maastricht, Netherlands

VieCuri Medisch Centrum; 🇳🇱 Venlo, Netherlands

UMC Utrecht; 🇳🇱 Utrecht, Netherlands

Elisabeth-TweeSteden Hospital; 🇳🇱 Tilburg, Netherlands