NCT04570527

Brief Summary

The purpose of this study is to investigate the efficacy and mechanism of Adipokines Cardiac Protection in Obese Patients With coronary artery disease (CAD).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

2.8 years

First QC Date

September 25, 2020

Last Update Submit

September 25, 2020

Conditions

Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))ObesityAdiposis; Heart

Keywords

Coronary artery diseaseAdipokinesObesityDiabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Number of patient death during the follow up period

    1 year

Secondary Outcomes (5)

  • Left ventricular ejection fraction

    1 year

  • Number of target vessel revascularization

    1 year

  • Angina class according to the canadian cardiovascular society (CCS) classification

    1 year

  • Scores on the Seattle angina questionnaire

    1 year

  • six-min walk distance (6MWD)

    1 year

Study Arms (2)

Obesity

BMI\>=25

Procedure: PCI

Non-Obesity

BMI\<25

Procedure: PCI

Interventions

PCIPROCEDURE

percutaneous coronary intervention

Non-ObesityObesity

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of CAD were enrolled in this study

You may qualify if:

  • coronary artery disease according to the WHO definition With or without percutaneous coronary intervention

You may not qualify if:

  • previous Coronary artery bypass grafting (CABG) cardiomyopathy atrial fibrillation or flutter previous heart surgery severe valvular heart disease disease of the hematopoietic system NYHA functional class IV heart failure at baseline severe renal, lung and liver disease cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (1)

  • Zhang X, Duan Y, Zhang X, Jiang M, Man W, Zhang Y, Wu D, Zhang J, Song X, Li C, Lin J, Sun D. Adipsin alleviates cardiac microvascular injury in diabetic cardiomyopathy through Csk-dependent signaling mechanism. BMC Med. 2023 May 26;21(1):197. doi: 10.1186/s12916-023-02887-7.

    PMID: 37237266DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma

MeSH Terms

Conditions

Coronary Artery DiseaseAngina PectorisMyocardial InfarctionObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInfarctionIschemiaPathologic ProcessesNecrosisOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Dongdong Sun, MD, PhD

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongdong Sun, MD, PhD

CONTACT

86 29 84775183wintersun3@gmail.com

Wanrong Man, MD

CONTACT

86 29 84775183Manwanrong@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiology department

Study Record Dates

First Submitted

September 25, 2020

First Posted

September 30, 2020

Study Start

January 1, 2019

Primary Completion

October 1, 2021

Study Completion

December 30, 2022

Last Updated

September 30, 2020

Record last verified: 2020-09

Locations

CN(1)