NCT02775279

Brief Summary

Compelling epidemiological evidence indicates that alterations length of telomere, are associated with the initiation and development of ischemic heart disease. This study was undertaken to investigate whether mtDNA copy number in peripheral blood leukocyte could be used as a risk predictor for acute coronary syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

4 months

First QC Date

May 14, 2016

Last Update Submit

May 14, 2016

Conditions

Keywords

acute coronary syndrome, telomere length, predictive factor

Outcome Measures

Primary Outcomes (1)

  • Relative telomere length

    the ratio of telomere repeat copy number(T) to the hemoglobin(HGB) copy number (S) was determined for each sample using standard curves. The derived T/S ratio was proportional to the relative telomere length(RTL). In the second step, the T/S ratio of each sample was normalized to a calibrator DNA to standardize between different PCR runs. The calibrated T/S ratio was then used as the measurement of RTL in this study.

    From date of percutaneous coronary intervention until the date of discharging from hospital, assessed up to 5 days

Study Arms (2)

Acute coronary syndrome group

200 consecutive patients were recruited, who have diagnosed with acute coronary syndrom(ACS) by quantitative coronary angiography.

Control group

The 200 healthy controls without previous CHD history were recruited from individuals who visited investigator's hospital for physical examination during the same time period as the case enrollment.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 200 eligible ACS patients were anticipated to include in this study.Moreover, The 200 healthy controls without previous CHD history were also recruited from individuals who visited investigator's hospital for physical examination during the same time period.

You may qualify if:

  • History of documented myocardial infarction; 2.Prior coronary revascularization intervention (coronary artery bypass graft surgery or percutaneous coronary intervention); 3.The presence of≥50% stenosis in one or more coronary arteries identified during cardiac catheterization;

You may not qualify if:

  • History of malignancy or end-stage renal disease; 2.Blood transfusion within one month or prior bone marrow transplantation 3.Patients who reluctant to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Telomeres consist of a tandem TTAGG repeat located at ends of linear chromosomes of eukaryote cells that often decrease in length over time (largely due to oxidative damage and the end replication problem during cell division) and may trigger cellular senescence once telomere become critically short

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

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

Study Record Dates

First Submitted

May 14, 2016

First Posted

May 17, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations