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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06601270




Registration number
NCT06601270
Ethics application status
Date submitted
15/10/2020
Date registered
19/09/2024

Titles & IDs
Public title
SCAD : a Registry of Spontaneous Coronary Artery Dissection
Scientific title
A Registry of Spontaneous Coronary Artery Dissection
Secondary ID [1] 0 0
SCAD registry
Universal Trial Number (UTN)
Trial acronym
SCAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spontaneous Coronary Artery Dissection 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - There are no interventions as the study is purely observational.

Retrospective - There are no interventions as the study is purely observational.

Prospective - There are no interventions as the study is purely observational.


Other interventions: There are no interventions as the study is purely observational.
There are no interventions as the study is purely observational.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient Status:
Timepoint [1] 0 0
Up to 5 years post-enrollment
Primary outcome [2] 0 0
Vital Signs:
Timepoint [2] 0 0
Up to 5 years post-enrollment
Primary outcome [3] 0 0
Recurrent SCAD Events:
Timepoint [3] 0 0
Up to 5 years post-enrollment
Primary outcome [4] 0 0
Imagery:
Timepoint [4] 0 0
Up to 5 years post-enrollment
Primary outcome [5] 0 0
Medications:
Timepoint [5] 0 0
Up to 5 years post-enrollment
Primary outcome [6] 0 0
Menstrual, Contraceptive, and Obstetric History:
Timepoint [6] 0 0
Up to 5 years post-enrollment
Primary outcome [7] 0 0
Discharge Information:
Timepoint [7] 0 0
Up to 5 years post-enrollment
Secondary outcome [1] 0 0
Procedures:
Timepoint [1] 0 0
Up to 5 years post-enrollment
Secondary outcome [2] 0 0
Other Coronary Vascular Events:
Timepoint [2] 0 0
Up to 5 years post-enrollment
Secondary outcome [3] 0 0
Symptomatology:
Timepoint [3] 0 0
Up to 5 years post-enrollment
Secondary outcome [4] 0 0
Pregnancy and Hormonal Therapy (when applicable):
Timepoint [4] 0 0
Up to 5 years post-enrollment
Secondary outcome [5] 0 0
Exercise History:
Timepoint [5] 0 0
Up to 5 years post-enrollment
Secondary outcome [6] 0 0
Mental Health and Wellbeing:
Timepoint [6] 0 0
Up to 5 years post-enrollment
Secondary outcome [7] 0 0
Employment Post-SCAD:
Timepoint [7] 0 0
At first follow-up visit only

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient unwilling or unable to consent
* Patients with iatrogenic or atherosclerotic coronary dissection

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Austria
State/province [4] 0 0
Wiener Neustadt
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruges
Country [6] 0 0
Belgium
State/province [6] 0 0
Brussels
Country [7] 0 0
Belgium
State/province [7] 0 0
Edegem
Country [8] 0 0
Belgium
State/province [8] 0 0
Genk
Country [9] 0 0
Belgium
State/province [9] 0 0
Gent
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Belgium
State/province [11] 0 0
Liège
Country [12] 0 0
Belgium
State/province [12] 0 0
Ottignies
Country [13] 0 0
Belgium
State/province [13] 0 0
Roeselare
Country [14] 0 0
Belgium
State/province [14] 0 0
Sint-Niklaas
Country [15] 0 0
Bosnia and Herzegovina
State/province [15] 0 0
Sarajevo
Country [16] 0 0
Brazil
State/province [16] 0 0
Sao Paulo
Country [17] 0 0
Brazil
State/province [17] 0 0
São Paulo
Country [18] 0 0
Croatia
State/province [18] 0 0
Split
Country [19] 0 0
Cyprus
State/province [19] 0 0
Nicosia
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Pardubice
Country [21] 0 0
Czech Republic
State/province [21] 0 0
Prague
Country [22] 0 0
Denmark
State/province [22] 0 0
Aarhus
Country [23] 0 0
Denmark
State/province [23] 0 0
Copenhagen
Country [24] 0 0
Denmark
State/province [24] 0 0
Hellerup
Country [25] 0 0
Denmark
State/province [25] 0 0
Odense
Country [26] 0 0
France
State/province [26] 0 0
Besançon
Country [27] 0 0
France
State/province [27] 0 0
Clermont-Ferrand
Country [28] 0 0
France
State/province [28] 0 0
Le Coudray
Country [29] 0 0
France
State/province [29] 0 0
Lyon
Country [30] 0 0
France
State/province [30] 0 0
Massy
Country [31] 0 0
France
State/province [31] 0 0
Pessac
Country [32] 0 0
Germany
State/province [32] 0 0
Bad Rothenfelde
Country [33] 0 0
Germany
State/province [33] 0 0
Berlin
Country [34] 0 0
Germany
State/province [34] 0 0
Hamburg
Country [35] 0 0
Germany
State/province [35] 0 0
Stuttgart
Country [36] 0 0
Greece
State/province [36] 0 0
Athens
Country [37] 0 0
Greece
State/province [37] 0 0
Kozani
Country [38] 0 0
Iran, Islamic Republic of
State/province [38] 0 0
Tehran
Country [39] 0 0
Italy
State/province [39] 0 0
Bergamo
Country [40] 0 0
Italy
State/province [40] 0 0
Foggia
Country [41] 0 0
Italy
State/province [41] 0 0
Genoa
Country [42] 0 0
Italy
State/province [42] 0 0
Mantua
Country [43] 0 0
Italy
State/province [43] 0 0
Milan
Country [44] 0 0
Italy
State/province [44] 0 0
Monza
Country [45] 0 0
Netherlands
State/province [45] 0 0
Alkmaar
Country [46] 0 0
Netherlands
State/province [46] 0 0
Breda
Country [47] 0 0
Netherlands
State/province [47] 0 0
Nijmegen
Country [48] 0 0
New Zealand
State/province [48] 0 0
Auckland
Country [49] 0 0
Norway
State/province [49] 0 0
Bergen
Country [50] 0 0
Poland
State/province [50] 0 0
Warsaw
Country [51] 0 0
Portugal
State/province [51] 0 0
Amadora
Country [52] 0 0
Portugal
State/province [52] 0 0
Braga
Country [53] 0 0
Portugal
State/province [53] 0 0
Tondela
Country [54] 0 0
Portugal
State/province [54] 0 0
Évora
Country [55] 0 0
Serbia
State/province [55] 0 0
Belgrade
Country [56] 0 0
Serbia
State/province [56] 0 0
Nis
Country [57] 0 0
Singapore
State/province [57] 0 0
Singapore
Country [58] 0 0
Slovakia
State/province [58] 0 0
Banska Bystrica
Country [59] 0 0
Spain
State/province [59] 0 0
Madrid
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Ashford
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Bodelwyddan
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Bournemouth
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Bristol
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Leicester
Country [65] 0 0
United Kingdom
State/province [65] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
European Society of Cardiology
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Adham GHARIEB, PharmD
Address 0 0
ESC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Adham GHARIEB, PharmD
Address 0 0
Country 0 0
Phone 0 0
048-388-1770
Fax 0 0
Email 0 0
agharieb@escardio.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06601270