Coronary VasospasmNL-CFTNCT06083155
The NetherLands Registry of Invasive Coronary Vasomotor Function Testing (NL-CFT)
An observational study of Coronary Vasospasm and Coronary Microvascular Dysfunction, run by Radboud University Medical Center at 15 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Vasospasm, Coronary Microvascular Dysfunction, Non-Obstructive Coronary Atherosclerosis
- What is being tested?
- Coronary Function Test and Patient questionnaires
- How many people
- 2,000 participants
- Where
- 15 sitesNetherlands
- Study dates
- 15 Oct 2020to Oct 2035
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients referred for clinically indicated CFT are eligible
Who may be able to join
- Referred for clinically indicated CFT
Who cannot join
- Not willing to provide informed consent
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Netherlands15 sites
Amsterdam UMC
Amsterdam
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam
Rijnstate Hospital
Arnhem
Amphia Hospital
Breda
Catharina Ziekenhuis
Eindhoven
Medisch Spectrum Twente
Enschede
Tergooi Hospital
Hilversum
Medisch Centrum Leeuwarden
Leeuwarden
Maastricht UMC
Maastricht
RadboudUMC
Nijmegen, Gelderland, 6525GA
Maasstad Ziekenhuis
Rotterdam
Haaglanden Medisch Centrum
The Hague
Elisabeth-TweeSteden Hospital
Tilburg
UMC Utrecht
Utrecht
VieCuri Medisch Centrum
Venlo
About this study
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.
- Conditions
- Coronary Vasospasm, Coronary Microvascular Dysfunction, Non-Obstructive Coronary Atherosclerosis
- Being tested
- Coronary Function Test, Patient questionnaires
- Medical subject headings
- Coronary Vasospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Function TestDiagnostic test
All participants are referred for a clinically indicated coronary function test
Patient questionnairesOther
All participants that consent will receive yearly followup questionnaires for 5 years after their initial consent
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Coronary Function Test; Other: 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 Receives: Diagnostic Test: Coronary Function Test; Other: Patient questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (2)
Angina burden
Measured by Seattle Angina Questionnaire summary score, 0-100 with higher scores indicating better (functional) status.
Measured: Baseline and every year up to 5 years after baseline
Experienced quality of life
Measured by Short Form 36, 0-100 with higher scores indicating better quality of life
Measured: Baseline and every year up to 5 years after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start15 Oct 2020
- Primary completionOct 2030 (estimated)
- Study completionOct 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary VasospasmStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Catharina Ziekenhuis Eindhoven, Maasstad Hospital, VieCuri Medical Centre, Frisius Medisch Centrum, Haaglanden Medical Centre, Rijnstate Hospital, Medisch Spectrum Twente, Onze Lieve Vrouwe Gasthuis, Tergooi Hospital, Amphia Hospital, Elisabeth-TweeSteden Ziekenhuis, Noordwest Ziekenhuisgroep, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Responsible party
- Sponsor
- Investigators
- Peter Damman, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083155
- Sponsor's protocol ID
- 79233
- Acronym
- NL-CFT
- Status last verified
- May 2024
- First submitted
- 23 Aug 2023
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only participating centers that signed the joint data registry agreement can make a request for data after approval of steering committee.
Publications
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.
PubMed 39818972
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NetherLands Registry of Invasive Coronary Vasomotor Function Testing (NL-CFT)
- ClinicalTrials.gov ID
- NCT06083155
- Acronym / sponsor ID
- NL-CFT / 79233
- Conditions
- Coronary Vasospasm, Coronary Microvascular Dysfunction, Non-Obstructive Coronary Atherosclerosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- UMC Utrecht, Catharina Ziekenhuis Eindhoven, Maasstad Hospital, VieCuri Medical Centre, Frisius Medisch Centrum, Haaglanden Medical Centre, Rijnstate Hospital, Medisch Spectrum Twente, Onze Lieve Vrouwe Gasthuis, Tergooi Hospital, Amphia Hospital, Elisabeth-TweeSteden Ziekenhuis, Noordwest Ziekenhuisgroep, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2035 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal CFT results: no coronary vasomotor dysfunction | – | Diagnostic Test: Coronary Function Test, Other: Patient questionnairesCollection 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 | – | Diagnostic Test: Coronary Function Test, Other: Patient questionnairesComparison 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients referred for clinically indicated CFT are eligible
Key inclusion criteria (1 listed)
- Referred for clinically indicated CFT
Key exclusion criteria (1 listed)
- Not willing to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Function TestAll participants are referred for a clinically indicated coronary function test | Diagnostic test | Abnormal CFT results: coronary vasomotor dysfunction, Normal CFT results: no coronary vasomotor dysfunction |
| Patient questionnairesAll participants that consent will receive yearly followup questionnaires for 5 years after their initial consent | Other | Abnormal CFT results: coronary vasomotor dysfunction, Normal CFT results: no coronary vasomotor dysfunction |
Primary outcome
Prevalence of coronary vasomotor dysfunction
Time frame: 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
2 secondary outcomes
Angina burden
Time frame: Baseline and every year up to 5 years after baseline
Experienced quality of life
Time frame: Baseline and every year up to 5 years after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Derived from this study: PubMed 39818972Crooijmans 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.
- Individual participant dataSharing planned: No. Only participating centers that signed the joint data registry agreement can make a request for data after approval of steering committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Damman principal investigator
Radboud University Medical Center
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Vasospasm and Coronary Microvascular Dysfunction, run by Radboud University Medical Center at 15 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of coronary vasomotor dysfunction (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06083155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.