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Recruiting Observational

SCAD : a Registry of Spontaneous Coronary Artery Dissection

NCT06601270 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2021-01-30
Last updated
2024-10-29

Condition(s) studied

Spontaneous Coronary Artery Dissection

Investigational drug(s) / intervention(s)

There are no interventions as the study is purely observational.

There are no interventions as the study is purely observational.: There are no interventions as the study is purely observational.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Patient unwilling or unable to consent * Patients with iatrogenic or atherosclerotic coronary dissection

Primary outcome measure(s)

  • Patient Status: — Up to 5 years post-enrollment
    * Measure: Functional health status and clinical condition during follow-up. * Unit of Measure: Categorized as stable, improved, or worsened.
  • Vital Signs: — Up to 5 years post-enrollment
    -Heart Rate: Measure: Heart rate monitoring. Unit of Measure: Beats per minute (bpm). -Blood Pressure: Measure: Systolic and diastolic blood pressure measurement. Unit of Measure: Millimeters of mercury (mmHg). -Oxygen Saturation: Measure: Oxygen saturation monitoring. Unit of Measure: Percentage (%).
  • Recurrent SCAD Events: — Up to 5 years post-enrollment
    * Measure: Documentation of recurrent SCAD events, including clinical presentation, diagnosis, management, and procedures. * Unit of Measure: Number of recurrent SCAD events.
  • Imagery: — Up to 5 years post-enrollment
    * Measure: Coronary angiography anonymized and sent for central review (Corelab) for confirmation and analysis. * Unit of Measure: Yes/No (whether imagery was obtained and sent).
  • Medications: — Up to 5 years post-enrollment
    Antiplatelet Medications: * Measure: Use of antiplatelet medications during follow-up. Unit of Measure: Number of antiplatelet medications prescribed. * Beta-Blockers: Measure: Use of beta-blocker medications during follow-up. Unit of Measure: Number of beta-blockers prescribed. -ACE Inhibitors/ARBs: Measure: Use of ACE inhibitors or angiotensin receptor blockers (ARBs) during follow-up. Unit of Measure: Number of ACE inhibitors/ARBs prescribed. -Calcium Channel Blockers: Measure: Use of calcium channel blockers during follow-up. Unit of Measure: Number of calcium channel blockers prescribed. -Statins: Measure: Use of statin medications during follow-up. Unit of Measure: Number of statins prescribed. -Other Medications (if applicable): Measure: Use of other medication classes during follow-up. Unit of Measure: Number and type of additional medications prescribed.
  • Menstrual, Contraceptive, and Obstetric History: — Up to 5 years post-enrollment
    * Measure: Menstrual status, use of contraceptives, and obstetric history during follow-up. * Unit of Measure: Categorical variables (e.g., premenopausal, postmenopausal; use of contraceptives: Yes/No).
  • Discharge Information: — Up to 5 years post-enrollment
    * Measure: Discharge status following SCAD-related hospital admissions. * Unit of Measure: Categorical variables (e.g., discharged to home, transferred to rehabilitation).

Trial sites (73)

FacilityCityRegionStatus
ICBA - Instituto Cardiovascular de Buenos Aires Buenos Aires Argentina Recruiting
Medical University of Innsbruck, Internal Medicine III Innsbruck Austria Recruiting
Klinik Landstrasse Vienna Austria Recruiting
Klinik Ottakring Vienna Austria Recruiting
Medical University of Vienna Vienna Austria Recruiting
Landesklinikum Wiener Neustadt Wiener Neustadt Austria Recruiting
AZ Sint jan, current president of Belgian ACCA Bruges Belgium Recruiting
Cliniques Universitaires Saint-Luc (UCL) Brussels Belgium Recruiting
Universitair Ziekenhuis Brussels Brussels Belgium Active Not Recruiting
Antwerp University Hospital Edegem Belgium Recruiting
Ziekenhuis Oost Limburg, Interventional cardiology/Coronary Care Genk Belgium Recruiting
AZ Sint Lucas hospital Ghent Belgium Active Not Recruiting
Ghent University Hospital Ghent Belgium Recruiting
University Hospitals Leuven Leuven Belgium Active Not Recruiting
CHR La Citadelle Liège Belgium Recruiting
Les cliniques Saint Pierre Ottignies Belgium Active Not Recruiting
AZ Delta Roeselare Belgium Recruiting
AZ Nikolaas Sint-Niklaas Belgium Recruiting
Clinical Center University of Sarajevo Sarajevo Bosnia and Herzegovina Recruiting
Hospital Israelita Albert Einstein São Paulo Brazil Recruiting
Instituto do Coração do HCFMUSP São Paulo Brazil Recruiting
Universidade Federal de São Paulo (UNIFESP) São Paulo Brazil Recruiting
University Hospital of Split (KBC Split) Split Croatia Recruiting
Nicosia General Hospital Nicosia Cyprus Recruiting
Nemocnice Pardubického kraje Pardubice Czechia Recruiting
Hospital Na Homolce Prague Czechia Recruiting
Aarhus University Hospital Aarhus Denmark Recruiting
Rigshospitalet Copenhagen Denmark Recruiting
Herlev and Gentofte Hospital Hellerup Denmark Recruiting
Odense University Hospital Odense Denmark Recruiting
CHRU Jean Minjoz Besançon France Recruiting
Gabriel Montpied Hospital - CHU Clermont-Ferrand Clermont-Ferrand France Recruiting
Hôpital de Chartres Louis Pasteur Le Coudray France Recruiting
Cardiovascular Hospital Louis Pradel - Hospices Civils de Lyon Lyon France Recruiting
Hôpital Jacques Cartier Massy France Recruiting
Hôpital Cardiologique du Haut Lévêque - Bordeaux University Pessac France Recruiting
Schüchtermann-Klinik Bad Rothenfelde Bad Rothenfelde Germany Recruiting
Vivantes Klinikum in Friedrichshain Berlin Germany Recruiting
University Heart and Vascular Center Hamburg Eppendorf Hamburg Germany Recruiting
Robert Bosch Hospital Stuttgart Germany Recruiting

+ 33 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06601270 on ClinicalTrials.gov ↗ ← All trials in Italy