Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))NCT04570527
Optimized Cardioprotection Therapy in Obese Subjects With CAD
An observational study of Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)) and Obesity, run by Xijing Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), Obesity, Adiposis; Heart
- What is being tested?
- PCI
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of CAD were enrolled in this study
Who may be able to join
- coronary artery disease according to the WHO definition With or without percutaneous coronary intervention
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing hospital
Xi'an, Shaanxi, 710032
Dongdong Sun, M.D.,Ph.D, 86 18691569930, wintersun3@gmail.com
Wanrong Man, M.D., 86 15352312311, manwanrong@gmail.com
About this study
Official title: Effects and Mechanism of Adipokines Cardiac Protection in Obese Patients With Coronary Artery Disease (CAD)
The purpose of this study is to investigate the efficacy and mechanism of Adipokines Cardiac Protection in Obese Patients With coronary artery disease (CAD).
Read the detailed description
Adipokines (or adipocytokines) can be defined as a group of more than 600 bioactive molecules made from adipose tissue that acts as paracrine and endocrine hormones. Adipokines are involved in maintaining varieties of processes such as, appetite and satiety, energy expenditure activity, endothelial function, blood pressure, hemostasis, adipogenesis, insulin sensitivity, energy metabolism in insulin-sensitive tissues, fat distribution and insulin secretion in pancreatic β-cells. Adipokines may contribute to reduce scar formation and improve cardiac function in coronary artery disease (CAD). Reperfusion therapy such as percutaneous coronary intervention (PCI) should be administered to all eligible patients with CAD symptom. However, our previous work showed that obese patients may benefit more from PCI. Thus, the aim of the present study was to investigate the efficacy and mechanism of adipokines cardiac protection for obese and non-obese patients with coronary artery disease (CAD).
- Conditions
- Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), Obesity, Adiposis; Heart
- Being tested
- PCI
- Keywords
- Coronary artery disease, Adipokines, Obesity, Diabetes mellitus
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Myocardial Infarction, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Obesity | BMI>=25 Receives: Procedure: PCI | |
| Non-Obesity | BMI<25 Receives: Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient death during the follow up period
Measured: 1 year
Secondary outcomes (5)
Left ventricular ejection fraction
Measured: 1 year
Number of target vessel revascularization
Measured: 1 year
Angina class according to the canadian cardiovascular society (CCS) classification
Measured: 1 year
Scores on the Seattle angina questionnaire
Measured: 1 year
six-min walk distance (6MWD)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start1 Jan 2019
- Primary completion1 Oct 2021 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))Studies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sunddong, Xijing Hospital
- Investigators
- Dongdong Sun, MD, PhD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570527
- Sponsor's protocol ID
- OB-CAD
- Status last verified
- Sep 2020
- First submitted
- 25 Sep 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37237266
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanism of Adipokines Cardiac Protection in Obese Patients With Coronary Artery Disease (CAD)
- ClinicalTrials.gov ID
- NCT04570527
- Acronym / sponsor ID
- OB-CAD
- Conditions
- Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), Obesity, Adiposis; Heart
- Keywords
- Coronary artery disease, Adipokines, Obesity, Diabetes mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the efficacy and mechanism of Adipokines Cardiac Protection in Obese Patients With coronary artery disease (CAD).
Detailed description
Adipokines (or adipocytokines) can be defined as a group of more than 600 bioactive molecules made from adipose tissue that acts as paracrine and endocrine hormones. Adipokines are involved in maintaining varieties of processes such as, appetite and satiety, energy expenditure activity, endothelial function, blood pressure, hemostasis, adipogenesis, insulin sensitivity, energy metabolism in insulin-sensitive tissues, fat distribution and insulin secretion in pancreatic β-cells. Adipokines may contribute to reduce scar formation and improve cardiac function in coronary artery disease (CAD). Reperfusion therapy such as percutaneous coronary intervention (PCI) should be administered to all eligible patients with CAD symptom. However, our previous work showed that obese patients may benefit more from PCI. Thus, the aim of the present study was to investigate the efficacy and mechanism of adipokines cardiac protection for obese and non-obese patients with coronary artery disease (CAD).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obesity | – | Procedure: PCIBMI>=25 |
| Non-Obesity | – | Procedure: PCIBMI<25 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of CAD were enrolled in this study
Key inclusion criteria (1 listed)
- coronary artery disease according to the WHO definition With or without percutaneous coronary intervention
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCIpercutaneous coronary intervention | Procedure or surgery | Non-Obesity, Obesity |
Primary outcome
Number of patient death during the follow up period
Time frame: 1 year
5 secondary outcomes
Left ventricular ejection fraction
Time frame: 1 year
Number of target vessel revascularization
Time frame: 1 year
Angina class according to the canadian cardiovascular society (CCS) classification
Time frame: 1 year
Scores on the Seattle angina questionnaire
Time frame: 1 year
six-min walk distance (6MWD)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Derived from this study: PubMed 37237266Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongdong Sun, MD, PhD principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)) and Obesity, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongdong Sun, MD, PhD (86 29 84775183, wintersun3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient death during the follow up period (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04570527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.