Acute Myocardial InfarctionNCT04570514
Optimized Cardioprotection Therapy in Obese Subjects With AMI
An observational study of Acute Myocardial Infarction and Myocardial Reperfusion Injury, 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 acute myocardial infarction (AMI) Who Have Undergone Percutaneous Coronary Intervention (PCI). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Acute Myocardial Infarction, Myocardial Reperfusion Injury, Obesity
- What is being tested?
- PCI
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 30 Dec 2020
- 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 AMI were enrolled in this study.
Who may be able to join
- age between 20 and 70 years old STEMI and NSTMI according to the WHO definition PCI <12 hours from the onset of symptoms
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects and Mechanism of Adipokines Cardiac Protection in Obese Patients With Acute Myocardial Infarction (AMI) Who Have Undergone Percutaneous Coronary Intervention (PCI).
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).
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 acute myocardial infarction (AMI). Reperfusion therapy such as percutaneous coronary intervention (PCI) should be administered to all eligible patients with AMI symptom onset within the prior 12 hours. 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 acute myocardial infarction (AMI) who have undergone PCI.
- Being tested
- PCI
- Keywords
- Adiposis, Obesity, Acute Myocardial Infarction, Percutaneous Coronary Intervention, Left Ventricular Function
- Medical subject headings
- Myocardial Reperfusion Injury, Obesity
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 (PCI)
| Study group | Role | What they receive |
|---|---|---|
| Obesity | Patients with Obesity. BMI>=25 Receives: Procedure: PCI | |
| Non-Obesity | Patients without 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 (7)
Left ventricular ejection fraction
Measured: 1 year
Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT)
Measured: 1 year
Infarct size as evaluated by Single-photon emission computed tomography (SPECT)
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 Oct 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 120 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, M.D.,Ph.D, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570514
- Sponsor's protocol ID
- OB-AMI
- 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
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 Acute Myocardial Infarction (AMI) Who Have Undergone Percutaneous Coronary Intervention (PCI).
- ClinicalTrials.gov ID
- NCT04570514
- Acronym / sponsor ID
- OB-AMI
- Keywords
- Adiposis, Obesity, Acute Myocardial Infarction, Percutaneous Coronary Intervention, Left Ventricular Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 30 Dec 2020 (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 acute myocardial infarction (AMI) Who Have Undergone Percutaneous Coronary Intervention (PCI).
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 acute myocardial infarction (AMI). Reperfusion therapy such as percutaneous coronary intervention (PCI) should be administered to all eligible patients with AMI symptom onset within the prior 12 hours. 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 acute myocardial infarction (AMI) who have undergone PCI.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obesity | – | Procedure: PCIPatients with Obesity. BMI>=25 |
| Non-Obesity | – | Procedure: PCIPatients without Obesity. BMI<25 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of AMI were enrolled in this study.
Key inclusion criteria (1 listed)
- age between 20 and 70 years old STEMI and NSTMI according to the WHO definition PCI <12 hours from the onset of symptoms
Key exclusion criteria (1 listed)
- 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
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 (PCI) | Procedure or surgery | Non-Obesity, Obesity |
Primary outcome
Number of patient death during the follow up period
Time frame: 1 year
7 secondary outcomes
Left ventricular ejection fraction
Time frame: 1 year
Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT)
Time frame: 1 year
Infarct size as evaluated by Single-photon emission computed tomography (SPECT)
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.
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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, M.D.,Ph.D 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 Acute Myocardial Infarction and Myocardial Reperfusion Injury, 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
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.