NCT04570514

Brief Summary

The purpose of this study is to investigate the efficacy and mechanism of Adipokines Cardiac Protection in Obese Patients With acute myocardial infarction (AMI) Who Have Undergone Percutaneous Coronary Intervention (PCI).

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 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

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 day until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

Same day

First QC Date

September 25, 2020

Last Update Submit

September 25, 2020

Conditions

Keywords

AdiposisObesityAcute Myocardial InfarctionPercutaneous Coronary InterventionLeft Ventricular Function

Outcome Measures

Primary Outcomes (1)

  • Number of patient death during the follow up period

    1 year

Secondary Outcomes (7)

  • Left ventricular ejection fraction

    1 year

  • Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT)

    1 year

  • Infarct size as evaluated by Single-photon emission computed tomography (SPECT)

    1 year

  • Number of target vessel revascularization

    1 year

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

    1 year

  • +2 more secondary outcomes

Study Arms (2)

Obesity

Patients with Obesity. BMI\>=25

Procedure: PCI

Non-Obesity

Patients without Obesity. BMI\<25

Procedure: PCI

Interventions

PCIPROCEDURE

percutaneous coronary intervention (PCI)

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 AMI were enrolled in this study.

You may qualify if:

  • age between 20 and 70 years old STEMI and NSTMI according to the WHO definition PCI \<12 hours from the onset of symptoms

You may not qualify if:

  • previous myocardial infarction (MI) 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

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma

MeSH Terms

Conditions

Myocardial Reperfusion InjuryObesity

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesReperfusion InjuryPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Study Officials

  • Dongdong Sun, M.D.,Ph.D

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
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

October 1, 2020

Primary Completion

October 1, 2020

Study Completion

December 30, 2020

Last Updated

September 30, 2020

Record last verified: 2020-09

Locations