Risk Factors of Intermediate Coronary Lesion Progression

NCT03855436 | Unknown

• 1 other identifier: Intermediate Lesion
• Study Type: observational
• Target: 1,389
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary intermediate lesions generally refer to lumen narrowing with diameter stenosis% (DS%) between 50% and 70% on angiography. Prognosis varies significantly among patients with intermediate lesions, and some lesions progress rapidly leading to adverse cardiovascular events. Therefore, accurate risk stratification is important and will help clinicians identify patients at high risk of adverse events. The aim of study is to identify independent risk factors for major adverse cardiovascular events (MACE) among patients with intermediate lesions. The study is a prospective, single-center, ongoing, observational study, which aims at enrolling approximately 1389 patients with intermediate coronary lesions. After enrollment, the following data are collected for each participant: baseline characteristics including demographics, clinical presentation, traditional risk factor, diagnosis and management; lesion characteristics assessed by coronary angiography; quantitative flow reserve; lab tests including blood chemistry, blood lipid, hemoglobin A1C, cardiac biomarker, BNP, et al. Patients are followed up at 2 year for primary outcome including death, myocardial infarction and repeat unplanned revascularization. A risk prediction score will be established and validated for major adverse cardiovascular disease at two-year follow-up.

Conditions

Coronary Atheroscleroses; Coronary Angiography

Keywords

coronary intermediate lesions; quantitative flow reserve; serum biomarker; risk score

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events (MACE)

  death, nonfatal myocardial infarction, repeat revascularization

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suspected of CAD and underwent elective coronary angiogram. Patients have signed written informed consent.

You may qualify if:

• Receiving elective coronary angiography
• Written informed consent
• One or more lesions located in main coronary arteries with intermediate stenosis (defined as diameter stenosis of 50%-70%)
• No lesions with significant stenosis (greater than 70%)

You may not qualify if:

• Unable to sign consent
• Receiving percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
• Planned PCI or CABG
• Left ventricle ejection fraction % (LVEF%)\<35% or cardiogenic shock
• Other severe comorbidities with life expectancy \<1 year

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Kefei Dou, MD, PhD

  National Center for Cardiovascular Diseases; Fuwai Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kefei Dou, MD, PhD

CONTACT

13801032912; drdoukefei@126.com

Chenxi Song, MD

CONTACT

18810991570; 1933769555@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 26, 2019
• Study Start: January 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)