## Protocol Section
### Identification Module
**NCT ID:** NCT02775279

**Brief Title:** Association Between Telomere Length and Risk of Acute Coronary Syndrome

**Official Title:** Short Telomere Length in Peripheral Blood Leukocyte Predicts the Risk of Acute Coronary Syndrome

#### Organization Study ID Info
**ID:** XJ20160520
#### Organization
**Class:** OTHER
**Full Name:** Air Force Military Medical University, China
### Status Module
#### Completion Date
**Date:** 2016-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-05-17

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-05-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-05

**Type:** ACTUAL

#### Start Date
**Date:** 2016-01

**Status Verified Date:** 2016-05

#### Study First Post Date
**Date:** 2016-05-17
**Type:** ESTIMATED
**Study First Submit Date:** 2016-05-14
**Study First Submit QC Date:** 2016-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Air Force Military Medical University, China

#### Responsible Party

**Investigator Affiliation:** Air Force Military Medical University, China

**Investigator Full Name:** Wenyi Guo

**Investigator Title:** Professor of Department of Cardiovascular Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Acute Coronary Syndrome

**Keywords:**

- acute coronary syndrome, telomere length, predictive factor

### Design Module

#### Bio Spec

**Description:** 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

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 400

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Label:** Acute coronary syndrome group

#### Arm Group 2

**Description:** 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.

**Label:** Control group

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Relative telomere length

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

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

-1.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;

Exclusion Criteria:

-1.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

**Healthy Volunteers:** True

**Maximum Age:** 85 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Xi'an

**Country:** China

**Facility:** Xijing Hospital

**State:** Shaanxi

**Zip:** 710032

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M27545

- Name: Acute Coronary Syndrome

- Relevance: HIGH

- As Found: Acute Coronary Syndrome

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000054058

- Term: Acute Coronary Syndrome

- ID: D000013577

- Term: Syndrome

### Misc Info Module

- Version Holder: 2024-05-24
