SCAD : a Registry of Spontaneous Coronary Artery Dissection

Официальное название

A Registry of Spontaneous Coronary Artery Dissection

Обзор

Spontaneous coronary artery dissection (SCAD) is an increasingly recognised cause of non-atherosclerotic acute coronary syndromes (ACS), predominantly afflicting young women without conventional atherosclerotic risk factors. Knowledge of SCAD has advanced considerably in the last few years as a result of data from a number of local and national registries 1-6. Like all rarer diseases however, a better understanding of SCAD will require international collaboration. At present, there is no European or International SCAD registry despite increasing recognition that there are key differences in the diagnosis, interventional and medical management of SCAD compared with conventional atherosclerotic ACS. The ESC-ACCA Study Group on Spontaneous Coronary Artery Dissection supported by the European Observational Research Programme will now build the first pan-European SCAD registry to advance our understanding of current management of this condition, inform guidelines, educate clinical colleagues and advance research.

Подробное описание

Observational, multicentre, international retrospective and prospective cohort study.

Since this is an observational study, a formal sample size is not necessary. At least 500 prospectively recruited patients and 500 historical cases will be enrolled.

Patient data will be collected at the following time-points:

* First SCAD event visit (retrospectively on chart review) * First follow-up: at time of enrolment * Yearly follow-up: up to 1, 2, 3, 4 and 5 years post enrolment or until study completion

Approximately 30 countries and 120 sites will participate in this registry.

Вмешательства

• Другое There are no interventions as the study is purely observational.
  There are no interventions as the study is purely observational.

Первичные конечные точки

• Patient Status: [Срок оценки: Up to 5 years post-enrollment]
• Vital Signs: [Срок оценки: Up to 5 years post-enrollment]
• Recurrent SCAD Events: [Срок оценки: Up to 5 years post-enrollment]
• Imagery: [Срок оценки: Up to 5 years post-enrollment]
• Medications: [Срок оценки: Up to 5 years post-enrollment]
• Menstrual, Contraceptive, and Obstetric History: [Срок оценки: Up to 5 years post-enrollment]
• Discharge Information: [Срок оценки: Up to 5 years post-enrollment]

Вторичные конечные точки (7)

• Procedures: [Срок оценки: Up to 5 years post-enrollment]
• Other Coronary Vascular Events: [Срок оценки: Up to 5 years post-enrollment]
• Symptomatology: [Срок оценки: Up to 5 years post-enrollment]
• Pregnancy and Hormonal Therapy (when applicable): [Срок оценки: Up to 5 years post-enrollment]
• Exercise History: [Срок оценки: Up to 5 years post-enrollment]
• Mental Health and Wellbeing: [Срок оценки: Up to 5 years post-enrollment]
• Employment Post-SCAD: [Срок оценки: At first follow-up visit only]

Критерии участия

Критерии включения

• Patient having signed an Informed Consent
• Patient aged 18 years and over
• SCAD clinical diagnosis within the past 10 years and available coronary angiographic imagery

Критерии исключения

• Patient unwilling or unable to consent
• Patients with iatrogenic or atherosclerotic coronary dissection

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бельгия · 12 центров

• AZ Sint jan, current president of Belgian ACCA — Bruges
• Cliniques Universitaires Saint-Luc (UCL) — Brussels
• Universitair Ziekenhuis Brussels — Brussels
• Antwerp University Hospital — Edegem
• Ziekenhuis Oost Limburg, Interventional cardiology/Coronary Care — Genk
• AZ Sint Lucas hospital — Ghent
• Ghent University Hospital — Ghent
• University Hospitals Leuven — Leuven
• … и ещё 4 центра

Италия · 8 центров

• Papa Giovanni XXIII Azienda Ospedaliera — Bergamo
• Policlinico Riuniti Foggia — Foggia
• Ospedale Policlinico San Martino IRCCS, Genova & Università di Genova — Genoa
• Presidio Ospedaliero Carlo Poma — Mantua
• ASST Grande Ospedale Niguarda — Milan
• Centro Cardiologico Monzino, IRCCS — Milan
• Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico — Milan
• Fondazione IRCCS San Gerardo dei Tintori — Monza

Великобритания · 7 центров

• William Harvey Hospital — Ashford
• Glan Clwyd Hospital — Bodelwyddan
• Bournemouth Hospital — Bournemouth
• Bristol Heart Institute — Bristol
• University Hospitals — Leicester
• Royal Brompton & Chelsea & Westminster Hospital — London
• Royal Free Hospital — London

Франция · 6 центров

• CHRU Jean Minjoz — Besançon
• Gabriel Montpied Hospital - CHU Clermont-Ferrand — Clermont-Ferrand
• Hôpital de Chartres Louis Pasteur — Le Coudray
• Cardiovascular Hospital Louis Pradel - Hospices Civils de Lyon — Lyon
• Hôpital Jacques Cartier — Massy
• Hôpital Cardiologique du Haut Lévêque - Bordeaux University — Pessac

Австрия · 5 центров

• Medical University of Innsbruck, Internal Medicine III — Innsbruck
• Klinik Landstrasse — Vienna
• Klinik Ottakring — Vienna
• Medical University of Vienna — Vienna
• Landesklinikum Wiener Neustadt — Wiener Neustadt

Дания · 4 центра

• Aarhus University Hospital — Aarhus
• Rigshospitalet — Copenhagen
• Herlev and Gentofte Hospital — Hellerup
• Odense University Hospital — Odense

Германия · 4 центра

• Schüchtermann-Klinik Bad Rothenfelde — Bad Rothenfelde
• Vivantes Klinikum in Friedrichshain — Berlin
• University Heart and Vascular Center Hamburg Eppendorf — Hamburg
• Robert Bosch Hospital — Stuttgart

Португалия · 4 центра

• Hospital Fernando Fonseca — Amadora
• Hospital de Braga — Braga
• Hospital do Espirito Santo de Evora — Evora
• Centro Hospitalar Tondela Viseu — Tondela

Бразилия · 3 центра

• Hospital Israelita Albert Einstein — São Paulo
• Instituto do Coração do HCFMUSP — São Paulo
• Universidade Federal de São Paulo (UNIFESP) — São Paulo

Нидерланды · 3 центра

• Noordwest Ziekenhuisgroep / NorthWest Clinics — Alkmaar
• Amphia Hospital — Breda
• Radboud University Medical Centre — Nijmegen

Чехия · 2 центра

• Nemocnice Pardubického kraje — Pardubice
• Hospital Na Homolce — Prague

Греция · 2 центра

• Sotiria Thoracic Diseases Hospital — Athens
• General Hospital of Kozani — Kozani

Сербия · 2 центра

• University Hospital Centre Bezanijska Kosa — Belgrade
• Cardiology Clinic, UCC Nis — Niš

Аргентина · 1 центр

• ICBA - Instituto Cardiovascular de Buenos Aires — Buenos Aires

Bosnia and Herzegovina · 1 центр

• Clinical Center University of Sarajevo — Sarajevo

Хорватия · 1 центр

• University Hospital of Split (KBC Split) — Split

Cyprus · 1 центр

• Nicosia General Hospital — Nicosia

Иран · 1 центр

• Tehran Heart Center — Tehran

Новая Зеландия · 1 центр

• Auckland City Hospital - Green Lane Cardiovascular Service — Auckland

Норвегия · 1 центр

• Haukeland University Hospital - Invasive cardiology — Bergen

Польша · 1 центр

• Institute of Cardiology - Department of Interventional Cardiology and Angiology — Warsaw

Сингапур · 1 центр

• National University Heart Centre Singapore — Singapore

Словакия · 1 центр

• Stredoslovensky ustav srdcovych a cievnych chorob a.s — Banská Bystrica

Испания · 1 центр

• Hospital Universitario de la Princesa — Madrid

Идентификаторы

NCT: NCT06601270 · SCAD registry

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗