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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Diagnostic Test: Coronary Function Test
* Other: Patient questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred for clinically indicated CFT Exclusion Criteria: Not willing to provide informed consent
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal CFT results: no coronary vasomotor dysfunction<br>Collection of data on anginal complaints, use of medication and major adverse cardiac events (MACE) by means of online patient questionnaires | Diagnostic Test: Coronary Function Test<br>* All participants are referred for a clinically indicated coronary function test<br>Other: Patient questionnaires<br>* All participants that consent will receive yearly followup questionnaires for 5 years after their initial consent<br>|
| Abnormal CFT results: coronary vasomotor dysfunction<br>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 | Diagnostic Test: Coronary Function Test<br>* All participants are referred for a clinically indicated coronary function test<br>Other: Patient questionnaires<br>* All participants that consent will receive yearly followup questionnaires for 5 years after their initial consent<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of coronary vasomotor dysfunction | Can be handled as dichotomous outcome with normal vs abnormal CFT results. Alternatively, can also be handled as categorical outcome with the following categories. Normal CFT results Vasospastic endotype (epicardial or microvascular); according to COVADIS criteria, following acetylcohline provocation testing) Microvascular dysfunction endotype (decreased coronary flow reserve or increased index of microvascular resistance) Mixed endotype | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |