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Risk Facotors in Young CHD Patients

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ClinicalTrials.gov Identifier: NCT03040869
Recruitment Status : Unknown
Verified February 2017 by Xu Lei, Shanghai Zhongshan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Xu Lei, Shanghai Zhongshan Hospital

Brief Summary:
Coronary heart disease (CHD) is the leading global cause of human death. Over the past decade, level of overall diagnosis and treatment of CHD has been greatly improved due to the progression of clinical research and development of technical means and the mortality of CHD has decreased by nearly 50% in western countries [1]. However, there are surveys shows that with the improvement of living standards and changes in lifestyle, the incidence of CHD is still rising in China and other developing countries, and the prevalence trend is obvious younger [2]. The so-called young CHD, generally refers to the age at onset of CHD is less than or equal to 45 years. Compared with other age-group CHD, young CHD has the following characteristics: 1. Genetic factors have a stronger effect at younger onset ages, and incidence with obvious familial aggregation[3]; 2 Often with the onset of acute coronary syndrome, presumably may be associated with strong inflammation of the lesion; 3. Two extremes often exists in coronary lesions: mild or no atherosclerosis and severe triple-vessel disease; 4 Rapid progression of atherosclerotic lesions, stent restenosis in the same site repeated after interventional treatment, rapid progress of lesion in non-intervention site;5 Surgical mortality is low in regardless of interventional therapy or bypass surgery, but the rate of revascularization is significantly higher in following 10 years.

Condition or disease
Risk Factor, Cardiovascular, Young CHD Patients

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Risk Factors Investigation in Young Patients With Coronary Artery Disease and Their Clinical Follow-up
Estimated Study Start Date : February 1, 2017
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : July 31, 2020

Group/Cohort
CHD Patients
coronary angioplasty confirmed coronary heart disease.
non-CHD patients
coronary angioplasty confirmed no coronary heart disease.



Primary Outcome Measures :
  1. heart failure [ Time Frame: 12 months ]
    LVEF less than 40%



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

①Below or equal to 45 years of age;

②Patients suffered stable or latent coronary heart disease, unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction diagnosed by coronary angiography or coronary CT scan;

Criteria

Inclusion Criteria:①Below or equal to 45 years of age;

②Patients suffered stable or latent coronary heart disease, unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction diagnosed by coronary angiography or coronary CT scan

Exclusion Criteria:

  • Patients who suffered serious liver and kidney diseases, infections, severe systemic disease such as blood disease and malignant tumor; ②Pregnancy or breast-feeding women; ③Patients who could not timely follow up or refuse to participate in this study.
Additional Information:

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Responsible Party: Xu Lei, Doctor, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03040869    
Other Study ID Numbers: 2016-02-25-1
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: laboratory test

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No