NCT03429517

Brief Summary

Background Changes in high-density lipoprotein cholesterol and triglyceride levels have been linked to residual cardiovascular risk, whereas non-high density lipoprotein levels have been shown to be more predictive of cardiovascular risk than are low-density lipoprotein cholesterol levels. We aimed to investigate the impact of high density lipoproteins, triglyceride, and non-high density lipoproteins levels on acute coronary syndrome risk with on-target low density lipoproteins levels.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

February 6, 2018

Last Update Submit

May 9, 2019

Conditions

Keywords

HDL-CTriglyceridesNon HDL-C and Acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

  • Decrease ACS events

    ACS and Dyslipidemia

    1 year

Study Arms (2)

Patients

ACS Lipogram

Diagnostic Test: Lipogram

Controls

Normal LDL-C level Lipogram

Diagnostic Test: Lipogram

Interventions

LipogramDIAGNOSTIC_TEST

liporgram samples

ControlsPatients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a first or subsequent ACS will be enrolled in our study, who are admitted to CCU of Assiut university hospital and Sohag cardiac \& digestive system center, more over patients should have LDL-C level below 130mg/dl and lipid samples should be obtained within 4 days of admission. They also should receive treatment according to ACS guidelines. Patients and control group data will be collected during a year . Patients will be subjected to: -Full History taking including : History of chest pain or dysnpea History of renal or liver diseases History of drug abuse History of diabetes and hypertension Family history of cardiovascular diseases and dyslipidemia Assessment of risk factors: smoking, alcohol intake, physical inactivity and poor quality diet. Patient Examination : Full general and cardiac examination including : Xanthelasma Body mass index Waist circumference

You may qualify if:

  • ACS
  • Normal LDL-C
  • Not on statin therapy

You may not qualify if:

  • Liver disease
  • Drug abuse
  • End stage renal disease
  • Nephrotic syndrome
  • Drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Assiut university hospital

Asyut, Egypt

RECRUITING

Sohag Cardiac and Digestive System Center

Sohag, Egypt

RECRUITING

Related Publications (1)

  • Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, Kirby A, Sourjina T, Peto R, Collins R, Simes R; Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005 Oct 8;366(9493):1267-78. doi: 10.1016/S0140-6736(05)67394-1. Epub 2005 Sep 27.

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Mahmoud Abdallah, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 12, 2018

Study Start

June 1, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2020

Last Updated

May 10, 2019

Record last verified: 2019-05

Locations