| CTRI Number |
CTRI/2017/09/009697 [Registered on: 11/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
08/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Central aortic blood pressure indices and coronary artery disease. |
|
Scientific Title of Study
|
The association between central aortic blood pressure indices and severity of coronary artery disease in a tertiary care center in North Kerala. |
| Trial Acronym |
CAPCAD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Ref No IRC/2013/Protocol/162/02-01-2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHREETAL RAJAN NAIR |
| Designation |
SENIOR RESIDENT |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE, CALICUT |
| Address |
SHREENIKETAN, 207/19, NETAJI ROAD, ALUVA, ERNAKULAM DISTRICT,INDIA
Kozhikode
KERALA
683101
India |
| Phone |
9895212678 |
| Fax |
|
| Email |
shreetal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHREETAL RAJAN NAIR |
| Designation |
SENIOR RESIDENT |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE, CALICUT |
| Address |
SHREENIKETAN, 207/19, NETAJI ROAD, ALUVA, ERNAKULAM DISTRICT,INDIA
Kozhikode
KERALA
683101
India |
| Phone |
9895212678 |
| Fax |
|
| Email |
shreetal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAJESH G |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE, CALICUT |
| Address |
SHREENIKETAN, 207/19, NETAJI ROAD, ALUVA, ERNAKULAM DISTRICT,INDIA
Dept of cardiology,
Superspeciality block, Govt medical college, Calicut
Kozhikode
KERALA
683101
India |
| Phone |
9895212678 |
| Fax |
|
| Email |
drrajeshgnair@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiology,Government medical college, Calicut |
|
|
Primary Sponsor
|
| Name |
Department of Cardiology |
| Address |
Department of cardiology, superspeciality block, post bag no 1 , government medical college, Kozhikode- 673008 |
| Type of Sponsor |
Government medical college |
|
|
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 SHREETAL RAJAN NAIR |
GOVERNMENT MEDICAL COLLEGE, CALICUT |
DEPARTMENT OF CARDIOLOGY, ROOM NO 116, FIRST FLOOR,SUPERSPECIALITY BLOCK, KOZHIKODE, KERALA, INDIA
Kozhikode
KERALA |
9895212678
shreetal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government medical college, Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing coronary angiogram for the diagnosis of coronary artery disease., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective angiography for diagnosis of CAD .
Adults greater than 18 years.
|
|
| ExclusionCriteria |
| Details |
Refusal to consent
Acute coronary syndrome (ACS) or thromboembolism in the preceding 3 months
Patients with peripheral vascular disease.
More than mild valvular heart disease.
Unable to obtain a full study of the coronary arteries.
Arrhythmias other than sinus bradycardia or sinus tachycardia.
Post CABG
Serum creatinine > 1.5 mg%
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DEATH, ACUTE CORONARY SYNDROME, STROKE |
6 MONTHS AFTER SUBJECT RECRUITMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| individual components of the primary outcome. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="575"
Sample Size from India="575"
Final Enrollment numbers achieved (Total)= "623"
Final Enrollment numbers achieved (India)="623" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2015 |
| Date of Study Completion (India) |
01/06/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Central aortic pressures have recently being increasingly recognised as important predictors cardiovascular outcomes. We in India have very limited data regarding the same and hence in our study we intend to study the central aortic pressures in patients who are undergoing coronary angiogram and to find out whether any association exists between central pressure indices and coronary artery disease.So also we also intend to follow up these patients after the initial enrollment phase for a period of 6 months to assess the incidence of MACE.Thus we also aim to study whether the central aortic pressures have any prognostic value in the prediction of future cardiovascular events. |