| CTRI Number |
CTRI/2020/03/023735 [Registered on: 03/03/2020] Trial Registered Prospectively |
| Last Modified On: |
02/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To find out association of Lipopotein(a)levels and heart problems in narrowed blood carrying artery due to plaque build up on the artery walls
|
|
Scientific Title of Study
|
Lipoprotein (a) Levels and Major Adverse Cardiac Events in Patients with Established Atherosclerotic Cardiovascular Disease
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Navaneeth |
| Designation |
PhD scholar |
| Affiliation |
Kasturba medical college and hospital,MAHE, Manipal |
| Address |
department of cardiology
kasutba medical college and hospital
MAHE ,manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8970892464 |
| Fax |
|
| Email |
naviamin7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tom Devasia |
| Designation |
professor and head |
| Affiliation |
Kasturba medical college and hospital,MAHE, Manipal |
| Address |
department of cardiology
kasutba medical college and hospital
MAHE ,manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448158508 |
| Fax |
|
| Email |
gt.cardiology@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Navaneeth |
| Designation |
PhD scholar |
| Affiliation |
Kasturba medical college and hospital,MAHE, Manipal |
| Address |
department of cardiology
kasutba medical college and hospital
MAHE ,manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8970892464 |
| Fax |
|
| Email |
naviamin7@gmail.com |
|
|
Source of Monetary or Material Support
|
| kasturba medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Manipal academy of Higher education |
| Address |
kasturba medical college and hospital
madhva nagar,maniapl-576104 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Navaneeth |
kasturba Hospital |
Department of cardiology, OPD block,room no :36
madhva nagar
manipal-576104
Udupi
KARNATAKA |
8970892464
naviamin7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kastuba medical college and kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. History of a myocardial infarction (MI) ≥3 months and ≤10 years before the study visit
2. History of ischemic stroke ≥ 3 months and ≤ 10 years before the study visit |
|
| ExclusionCriteria |
| Details |
1.Patients currently enrolled in clinical
studies with investigational drugs
2.Patients with proven Psychiatric illness on
medications
3.Patients with chronic liver disease
4.Pregnant women
5.Terminal malignancy patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Association of elevated Lp(a) in established cardiovascular disease (CVD)
2.Identifying relationship between raised levels of Lp(a) and other biochemical parameters including lipid profile among the sub group population with established ASCVD
3.Identifying association of anthropometric parameters with Lp(a) levels in patients with established ASCVD
4.Co-relation between Lp(a) and MACE rate on 18 months follow up of patients with documented ASCVD on standard medical therapy including statins
|
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association of elevated Lp(a) in established cardiovascular disease (CVD)
• Co-relation between Lp(a) and MACE rate on 18 months follow up of patients with documented ASCVD on standard medical therapy including statins
|
3years |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
04/03/2020 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Lipoprotein(a) has
been considered a cardiovascular risk factor for many years. Although
prospective, randomized, controlled outcomes studies have not been conducted,
epidemiological, genome-wide association and Mendelian randomized controlled
study data provide supporting evidence for a role of Lp(a) in CVD . however this trail help to understand the association of Lp(a) and major adverse cardiac events related to the elevated Lp(a) levels in atherosclerotic cardiovascular disease. |