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

NCT ID: NCT06083155

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-15

Study Completion Date

2035-10-31

Brief Summary

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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

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Conditions

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Coronary Vasospasm Coronary Microvascular Dysfunction Non-Obstructive Coronary Atherosclerosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Coronary Function Test

Intervention Type DIAGNOSTIC_TEST

All participants are referred for a clinically indicated coronary function test

Patient questionnaires

Intervention Type OTHER

All participants that consent will receive yearly followup questionnaires for 5 years after their initial consent

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

Coronary Function Test

Intervention Type DIAGNOSTIC_TEST

All participants are referred for a clinically indicated coronary function test

Patient questionnaires

Intervention Type OTHER

All participants that consent will receive yearly followup questionnaires for 5 years after their initial consent

Interventions

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Coronary Function Test

All participants are referred for a clinically indicated coronary function test

Intervention Type DIAGNOSTIC_TEST

Patient questionnaires

All participants that consent will receive yearly followup questionnaires for 5 years after their initial consent

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Referred for clinically indicated CFT

Exclusion Criteria

* Not willing to provide informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role collaborator

Maasstad Hospital

OTHER

Sponsor Role collaborator

VieCuri Medical Centre

OTHER

Sponsor Role collaborator

Frisius Medisch Centrum

OTHER

Sponsor Role collaborator

Haaglanden Medical Centre

OTHER

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role collaborator

Medisch Spectrum Twente

OTHER

Sponsor Role collaborator

Onze Lieve Vrouwe Gasthuis

OTHER

Sponsor Role collaborator

Tergooi Hospital

OTHER

Sponsor Role collaborator

Amphia Hospital

OTHER

Sponsor Role collaborator

Elisabeth-TweeSteden Ziekenhuis

OTHER

Sponsor Role collaborator

Noordwest Ziekenhuisgroep

OTHER

Sponsor Role collaborator

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Damman

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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RadboudUMC

Nijmegen, Gelderland, Netherlands

Site Status

Amsterdam UMC

Amsterdam, , Netherlands

Site Status

Onze Lieve Vrouwe Gasthuis (OLVG)

Amsterdam, , Netherlands

Site Status

Rijnstate Hospital

Arnhem, , Netherlands

Site Status

Amphia Hospital

Breda, , Netherlands

Site Status

Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status

Medisch Spectrum Twente

Enschede, , Netherlands

Site Status

Tergooi Hospital

Hilversum, , Netherlands

Site Status

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

Site Status

Maastricht UMC

Maastricht, , Netherlands

Site Status

Maasstad Ziekenhuis

Rotterdam, , Netherlands

Site Status

Haaglanden Medisch Centrum

The Hague, , Netherlands

Site Status

Elisabeth-TweeSteden Hospital

Tilburg, , Netherlands

Site Status

UMC Utrecht

Utrecht, , Netherlands

Site Status

VieCuri Medisch Centrum

Venlo, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 39818972 (View on PubMed)

Other Identifiers

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79233

Identifier Type: -

Identifier Source: org_study_id

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