Observational study to understand the profile of heart diseases and compare with other country

Not Applicable

Completed

• Conditions: Health Condition 1: null- -Age 18 years and above-Written informed consent for participation- Hospitalized for acute coronary syndrome-Prior angioplasty or Prior bypass surgery

• Registration Number: CTRI/2013/07/003804
• Lead Sponsor: Merck Co Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10500

Inclusion Criteria

DYSIS II ACS

• Age >= 18 years

• Hospitalized for acute coronary syndrome (ACS) (ST segment elevation myocardial infarction (STEMI), left bundle branch block (LBBB), Non-ST elevated myocardial infarction (NSTEMI), unstable angina) at time of enrolment

• Full lipid profile available based on blood drawn within 24 hours of admission to the hospital.

• On lipid-modifying therapy (LMT) for equal to or more than 3 months at time of enrolment, or NOT at all on LMT.

DYSIS II CHD

• Age >= 18 years

• Documented CHD by at least one of the following:

o coronary angiography (stenosis >50%)

o cardiac computed tomography (CT) (stenosis > 50%)

o prior percutaneous coronary intervention (PCI) or prior coronary artery bypass graft (CABG)

o history of ACS >3 months prior to enrolment

o Complete fasting lipid profile 0-12 months prior to enrollment while on lipid modifying therapy (LMT) for equal to or more than 3 months or not at all on LMT

Exclusion Criteria

DYSIS II ACS

• Patients treated with lipid-modifying therapy for more than 0 but less than 3 months at the time of enrolment

DYSIS II CHD

• History of ACS within 3 months prior to enrollment

• Participation in DYSIS II ACS

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this observational study is to document real life lipid levels in patients with stable CHD (stable CHD or ACS) <br/ ><br> <br/ ><br>Timepoint: Time point for assessment for Stable CHD is when patient report or visit to treating physician for routine follow-up <br/ ><br> <br/ ><br>Time Point for Data collection of ACS patients - When patient is discharged after successful ACS treatment. Thereafter telephonic follow-up 16 weeks post discharge