Multi-center cross-sectional epidemiological study tounderstand the prevalence and distribution oflipoprotein(a) levels among patients with establishedcardiovascular disease

Recruiting

• Conditions: Chronic ischemic heart disease, unspecified,

• Registration Number: CTRI/2019/04/018392
• Lead Sponsor: Novartis Healthcare Pvt Ltd

Brief Summary

This is a Multi-center cross-sectional epidemiological study to characterize the prevalence and distribution of lipoprotein(a) levels among patients with established cardiovascular disease. The purpose of this study is to To evaluate the prevalence of normal and elevated Lp(a) levels in patients with established CVD.

Target FPFV for India is 30-April-2019.



Sample size for India: 3250

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-30
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 45000

Inclusion Criteria

• Signed informed consent must be obtained prior to participation in the study 2.
• Male and female ≥ 18 to ≤ 80 years of age 3.
• Established CVD defined as one of the following: -History of a myocardial infarction (MI) ≥3 months and ≤10 years before the study visit -History of ischemic stroke ≥ 3 months and ≤ 10 years before the study visit -Symptomatic PAD (intermitted claudication with ankle-brachial index.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the prevalence of normal and elevated Lp(a) levels in patients with established	One Day
CVD	One Day

Secondary Outcome Measures

Name	Time	Method
-To evaluate the median and other relevant	statistics describing the distribution of Lp(a) within

Trial Locations

Locations (38)

Amrita Institute of Medical Sciences & Research Centre; 🇮🇳 Ernakulam, KERALA, India

Apollo Hospitals; 🇮🇳 Chennai, TAMIL NADU, India

Apollo Hospitals International Limited; 🇮🇳 Ahmadabad, GUJARAT, India

Artemis Hospitals; 🇮🇳 Gurgaon, HARYANA, India

 Jehangir Clinical Development Center Pvt.Ltd.; 🇮🇳 Pune, MAHARASHTRA, India

 Yashoda Hospital; 🇮🇳 Hyderabad, TELANGANA, India

B.J. Govt. Medical College & Sassoon General Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Bhaktivedanta Hospital and Research Institute; 🇮🇳 Thane, MAHARASHTRA, India

CIMS Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

COLUMBIA ASIA HOSPITALS PRIVATE LIMITED; 🇮🇳 Mysore, KARNATAKA, India

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Amrita Institute of Medical Sciences & Research Centre

🇮🇳Ernakulam, KERALA, India

Dr Rajiv C

Principal investigator

9846562541

rajivc@aims.amrita.edu