NCT04070014

Brief Summary

Aim of this study is to investigate the relationship between heme oxygenase-1 enzyme level and angiographically determined SYNTAX score in patients with suspected stable coronary artery disease. Consecutive patients who are deemed to undergo coronary angiography due to high pre test probability or evidence of cardiac ischemia in imaging studies will be included in the study. Patients with coronary artery bypass surgery history and severe comorbid illnesses such as active malignancy, chronic obstructive lung disease, stage 3-5 chronic renal failure will be excluded. Serum heme oxygenase levels will be measured by ELISA method and SYNTAX score will be calculated from coronary angiography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

August 22, 2019

Last Update Submit

June 19, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relationship between serum heme oxygenase-1 enzyme level and SYNTAX score

    Correlation between serum heme oxygenase levels (in pg/ml) and angiographically determined SYNTAX scores (no unit) will be determined statistically.

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients from a single center with suspected stable coronary artery disease who are deemed to undergo coronary angiographic evaluation will be included in the study. Patients will be recruited in a non randomized fashion.

You may qualify if:

  • Patients with suspected stable coronary artery disease who are deemed to undergo coronary angiographic evaluation

You may not qualify if:

  • Patients with history of coronary bypass or other cardiac surgery
  • Patients with acute coronary syndrome
  • Patients with severe comorbid illnesses including active malignancies, stage 3-5 chronic renal failure, chronic obstructive lung disease
  • Patients with clinically overt infectious or inflammatory diseases
  • Patients taking medications that possibly interact with heme metabolism
  • patients with hemoglobinopathies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University Hospital

Istanbul, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum obtained from peripheral blood will be used.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

October 1, 2019

Primary Completion

November 25, 2019

Study Completion

March 30, 2020

Last Updated

June 22, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations