NCT04888260

Brief Summary

Aims: Nondiabetic patients have been studied to determine whether modest elevations in plasma mannose levels may be associated with a greater incidence of coronary artery disease (CAD). Methods: The plasma mannose, lipids (triglyceride, LDL, HDL, LDL, VLDL) and LDH levels were successfully will be evaluated with respect to subsequent coronary artery disease using records 120 nondiabetic patients and 120 healthy volunteers. CAD was identified from myocardial infarction and new diagnoses of angina. The associations between mannose levels and serum lipid parameters will be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

January 10, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

2.3 years

First QC Date

May 7, 2021

Last Update Submit

May 11, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlations between mannose levels and serum lipid parameters

    This outcome aims to investigate the correlations between mannose levels and serum lipid parameters in patients who have body mass index under than 25 (kg/m\^2) and over than 25 kg/m\^2.

    16 Months

Secondary Outcomes (2)

  • Correlations between mannose levels and infection parameters (CRP and others).

    6 months

  • The effect of comorbidites on correlation between the serum mannose levels and serum lipid parameters and serum infecition parameters

    6 months

Study Arms (2)

Coronary Artery Disease Group

Patients who underwent angiography at the Department of Cardiology and newly diagnosed as coronary artery disease and who weren't on statin treatment were included in the patient group.

Other: Laboratory parameter levels in blood samples

Control Group

The control group consisted of healthy people with normal coronary arteries angiographically

Other: Laboratory parameter levels in blood samples

Interventions

Mannose and lipid parameters (triglyceride, LDL, HDL, VLDL) will be analysed in blood samples by using ELISA method.

Control GroupCoronary Artery Disease Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patient and control groups will be initially informed about the study and obtained a written consent. Patients who underwent angiography at the Department of Cardiology and newly diagnosed as coronary artery disease and who weren't on statin treatment will be included in the patient group. The control group will be consisted of healthy people with normal coronary arteries angiographically. Patients with chronic renal failure, chronic liver disease, inflammatory disease, diabetes, insulin resistance, major metabolic or endocrine disease will also be excluded. For this purpose, age and sex matched 120 patients and 120 healthy volunteers will be admitted to study.

You may not qualify if:

  • To be on statin treatment. To underwent angiography at the another department or university. Not to be newly diagnosed as coronary artery disease. To have a chronic renal failure, chronic liver disease, inflammatory disease, diabetes, insulin resistance, major metabolic or endocrine disease.
  • For Control Group;
  • To give written informed consent. To underwent angiography at the Pamukkale University Department of Cardiology. To have normal coronary angiography. Not to be on statin treatment.
  • To be on statin treatment. To underwent angiography at the another department or university. To have a chronic renal failure, chronic liver disease, inflammatory disease, diabetes, insulin resistance, major metabolic or endocrine disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aylin Koseler

Denizli, Outside of the US, 20070, Turkey (Türkiye)

Location

Ramazan Sabirli

Kars, Outside of the US, 36000, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be used.

MeSH Terms

Conditions

Coronary Artery DiseaseHyperlipidemias

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

May 7, 2021

First Posted

May 17, 2021

Study Start

January 10, 2018

Primary Completion

May 10, 2020

Study Completion

May 15, 2020

Last Updated

May 17, 2021

Record last verified: 2021-05

Locations