Design and rationale of the NetherLands registry of invasive Coronary vasomotor Function Testing (NL-CFT). (15th May 2023)

• Record Type: Journal Article
• Authors: Crooijmans, C.; Jansen, T.P.J.; Konst, R.E.; Woudstra, J.; Appelman, Y.; den Ruijter, H.M.; Onland-Moret, N.C.; Meeder, J.G.; de Vos, A.M.J.; Paradies, V.; Woudstra, P.; Sjauw, K.D.; van 't Hof, A.; Meuwissen, M.; Winkler, P.; Boersma, E.; van de Hoef, T.P.; Maas, A.H.E.M.; Dimitriu-Leen, A.C.; van Royen, N.; Elias-Smale, S.E.; Damman, P.
• Is Part Of: International journal of cardiology. Volume 379(2023)
• Page Start: 1
• Page End: 8
• Publication Date: 2023-05-15
• Subjects: Coronary function test -- Angina with no obstructive coronary artery disease (ANOCA) -- Coronary microvascular dysfunction -- Coronary artery spasm -- Registry; ACH acetylcholine -- ANOCA angina with no obstructive coronary artery disease -- APV average peak Doppler flow velocity -- BMI body mass index -- CAD coronary artery disease -- CBS statistics Netherlands (centraal bureau voor de statistiek) -- CFR coronary flow reserve -- CFT coronary function test -- DRE digital research environment -- ECG electrocardiogram -- EDC electronic data capture -- FAIR findable, accessible, interoperable, reusable -- FFR fractional flow reserve -- GDPR general data protection regulation -- HMR hyperemic microvascular resistance -- IMR index of microvascular resistance -- MRR microvascular resistance reserve -- NL-CFT the NetherLands registry of invasive Coronary vasomotor Function Testing -- Q flow -- R resistance -- RRCT registry based randomized clinical trials -- SAQ Seattle Angina Questionnaire -- WMO Medical Research Involving Human Subjects Act (wet medisch- wetenschappelijk onderzoek met mensen); Cardiology -- Periodicals; Electronic journals; 616.12
• DOI: 10.1016/j.ijcard.2023.02.043
• Languages: English
• ISSNs: 0167-5273

Abstract

Abstract: Background: Angina without angiographic evidence of obstructive coronary artery disease (ANOCA) is a highly prevalent condition with insufficient pathophysiological knowledge and lack of evidence-based medical therapies. This affects ANOCA patients prognosis, their healthcare utilization and quality of life. In current guidelines, performing a coronary function test (CFT) is recommended to identify a specific vasomotor dysfunction endotype. The NetherLands registry of invasive Coronary vasomotor Function testing (NL-CFT) has been designed to collect data on ANOCA patients undergoing CFT in the Netherlands. Methods: The NL-CFT is a web-based, prospective, observational registry including all consecutive ANOCA patients undergoing clinically indicated CFT in participating centers throughout the Netherlands. Data on medical history, procedural data and (patient reported) outcomes are gathered. The implementation of a common CFT protocol in all participating hospitals promotes an equal diagnostic strategy and ensures representation of the entire ANOCA population. A CFT is performed after ruling out obstructive coronary artery disease. It comprises of both acetylcholine vasoreactivity testing as well as bolus thermodilution assessment of microvascular function. Optionally, continuous thermodilution or Doppler flow measurements can be performed. Participating centers can perform research using own data, or pooled data will be made available upon specific request via a secure digital research environment, after approval of a steering committee. Conclusion: NL-CFT will be an important registry by enabling both observational and registry based (randomized) clinical trials in ANOCA patients undergoing CFT. Highlights: NL-CFT is a web-based, prospective, observational registry. All consecutive ANOCA patients undergoing clinically indicated CFT are included. NL-CFT enables both observational and registry based (randomized) clinical trials.