| CTRI Number |
CTRI/2023/12/060936 [Registered on: 29/12/2023] Trial Registered Prospectively |
| Last Modified On: |
27/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Diagnosis and management of Spontaneous coronary artery dissection (SCAD) |
|
Scientific Title of Study
|
A registry of Spontaneous coronary artery dissection (SCAD) |
| Trial Acronym |
SCAD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Roopa Salwan |
| Designation |
Senior Director |
| Affiliation |
Max Super Speciality Hospital Saket |
| Address |
Max Super Speciality Hospital Saket (a unit of Devki devi foundation) 2 press enclave road Saket New delhi
Max Super Speciality Hospital Saket (a unit of Devki devi foundation) 2 press enclave road Saket New delhi
South
DELHI
110017
India |
| Phone |
9811013643 |
| Fax |
|
| Email |
roopa.salwan@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa Salwan |
| Designation |
Senior Director |
| Affiliation |
Max Super Speciality Hospital Saket |
| Address |
Max Super Speciality Hospital Saket (a unit of Devki devi foundation) 2 press enclave road Saket New delhi
Max Super Speciality Hospital Saket (a unit of Devki devi foundation) 2 press enclave road Saket New delhi
South
DELHI
110017
India |
| Phone |
9811013643 |
| Fax |
|
| Email |
roopa.salwan@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roopa Salwan |
| Designation |
Senior Director |
| Affiliation |
Max Super Speciality Hospital Saket |
| Address |
Max Super Speciality Hospital Saket (a unit of Devki devi foundation) 2 press enclave road Saket New delhi
Max Super Speciality Hospital Saket (a unit of Devki devi foundation) 2 press enclave road Saket New delhi
South
DELHI
110017
India |
| Phone |
9811013643 |
| Fax |
|
| Email |
roopa.salwan@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
EURObservational Research Programme (EORP) |
| Address |
Maison européenne du Coeur/ European Heart House
Les Templiers
2035 Route des Colles
CS 80179 Biot
06903 Sophia Antipolis Cedex France |
| Type of Sponsor |
Other [European Society of Cardiology (ESC)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Roopa Salwan |
Max Super Speciality Hospital (A unit of Devki Devi Foundation) |
Max Super Speciality Hospital (A unit of Devki Devi Foundation), 2, Press Enclave Road, Saket, New-Delhi: 110017
South
DELHI |
9811013643
roopa.salwan@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having signed an Informed Consent
2. Patient aged 18 years and over
3. SCAD clinical diagnosis within the past 10 years and available coronary angiographic imagery |
|
| ExclusionCriteria |
| Details |
1. Patient unwilling or unable to consent
2. Patients with coronary dissection in association with atherosclerotic disease or isolated iatrogenic dissection (not definitely occurring in a patient with SCAD) will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. RECURRENT SCAD
2. SIGNIFICANT MACE
3. Risk of periprocedural complications including iatrogenic dissection during coronary angiography or PCI.
4. Proportion of cases are due to Peri-partum SCAD
5. Risk of pregnancy in SCAD-survivors
6. Risk of hormonal contraception/Hormone Replacement therapy (HRT) in SCAD-survivors
7. Early management of SCAD |
5 YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Compare data between countries
2. To analyse and report these data as research publications and health reports to the wider European Society of Cardiology (ESC) community |
5 YEARS |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/12/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
SCAD is a neglected area of knowledge regarding current European medical practice and as such represents a significant unmet clinical need for our patients. It has a disproportionate impact on women, frequently with careers and young families. There remain significant gaps in our knowledge of the epidemiology, presentation, current management and outcome for SCAD-survivors. Ultimately effective rare disease research requires a collaborative approach.
|