| CTRI Number |
CTRI/2019/03/017933 [Registered on: 06/03/2019] Trial Registered Prospectively |
| Last Modified On: |
05/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Using markers of coronary artery disease to gain information about the disease |
|
Scientific Title of Study
|
Correlation of biomarkers with plaque rupture versus erosion in Acute Coronary syndromes: Optical Coherence Tomography based study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreenivas Reddy |
| Designation |
Professor and Head |
| Affiliation |
Govt Medical College and Hospital, Chandigarh |
| Address |
Cardiology
GMCH
sector 32
Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
|
| Fax |
|
| Email |
reddycardio2911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreenivas Reddy |
| Designation |
Professor and Head |
| Affiliation |
Govt Medical College and Hospital, Chandigarh |
| Address |
Cardiology
GMCH
sector 32
Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
|
| Fax |
|
| Email |
reddycardio2911@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreenivas Reddy |
| Designation |
Professor and Head |
| Affiliation |
Govt Medical College and Hospital, Chandigarh |
| Address |
Cardiology
GMCH
sector 32
Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
|
| Fax |
|
| Email |
reddycardio2911@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Medical College and Hospital, Sector 32, Chandigarh - 160047. |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
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 S REDDY |
Govt Medical College, Cardiology dept. |
Sector 32
Chandigarh
CHANDIGARH |
9417495680
reddycardio2911@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GMCH CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I222||Subsequent non-ST elevation (NSTEMI) myocardial infarction, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients presenting with Acute Coronary syndromes (STEMI, NSTEMI, Unstable Angina with ≥10 minutes of angina or anginal equivalent consistent with unstable angina or myocardial infarction (MI) within 72 hours, with either elevated cardiac biomarkers (CK-MB or troponin) or ST-segment deviation of >1 mm in ≥2 contiguous electrocardiographic leads) to EMOPD or OPD of the Department of Cardiology at GMCH-32, will be included. |
|
| ExclusionCriteria |
| Details |
1. Cardiogenic shock.
2. Left Ventricular Failure (Killip Class 3 or 4).
3. Serum creatinine ≥2.5 mg/dl.
4. Known allergy, hypersensitivity or contraindication to aspirin, heparin, or contrast.
5. Significant gastrointestinal or urinary bleed within the past 6 weeks, coagulopathy or bleeding diathesis.
6. Deranged LFTs like bilirubin >1.5mg/dl and enzymes 2 to 3 times elevated above upper limit of normal.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association of biomarkers of inflammation with the type of plaque morphology. |
30 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of the systemic biomarkers of inflammation and the coronary blood biomarkers of inflammation. |
30 days. |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
01/04/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of this study is to find the correlation biomarkers of inflammation with the plaque morphology, plaque rupture and plaque erosion detected on Intravascular Imaging by Optical Coherence Tomography in acute coronary syndrome patients and six months clinical outcomes. As the there is relative high incidence of CAD in India as compared to the western population, early diagnosis with biomarkers of the vulnerable plaque or the vulnerable patient will help initiating appropriate therapy and prevent acute coronary syndromes. The biomarkers will help to assist in making management algorithms based on the biomarkers and its correlation with type of ACS. This helps to decide as to when to initiate the medical therapy or aggressive therapy based on the correlation of biomarkers |