Acute Coronary SyndromeNCT04405856
Outcome of Patients Treated With IABP
An observational study of Acute Coronary Syndrome and Cardiogenic Shock, run by Nanjing Medical University at 1 site in China.
Trial summary
Intra-Aortic Balloon Pumps (IABP) is a widely used and effective left ventricular adjuvant therapy. IABP is an inflatable device placed in the aorta that inflates with diastole and deflates with systole. Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Acute Coronary Syndrome, Cardiogenic Shock, Coronary Artery Disease
- What is being tested?
- Intra Aortic Balloon Pump
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2012to 31 Dec 2025
- 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 1 year to 100 years
- All sexes
- Child, Adult, Older adult
Study population: Patients receiving IABP for circulatory support
Who may be able to join
- Patients receiving IABP for circulatory support
Who cannot join
- Refusal of consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of nanjing medical university
Nanjing, Jiangsu, 210029
Hong Liu, MD, 188012181613, dr.hongliu@foxmail.com
About this study
Official title: Outcome of Patients Treated With Intra Aortic Balloon Pump
Intra-Aortic Balloon Pumps (IABP) is a widely used and effective left ventricular adjuvant therapy. IABP is an inflatable device placed in the aorta that inflates with diastole and deflates with systole. The aim of this study is to investigate the outcome of patients treated With IABP, and to evaluate the short-term and long-term outcomes of patients with IABP.
- Conditions
- Acute Coronary Syndrome, Cardiogenic Shock, Coronary Artery Disease, Heart Failure, Left Ventricular Dysfunction, Low Cardiac Output Syndrome
- Being tested
- Intra Aortic Balloon Pump
- Medical subject headings
- Acute Coronary Syndrome, Shock, Cardiogenic, Coronary Artery Disease, Heart Failure, Ventricular Dysfunction, Left, Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra Aortic Balloon PumpDevice
Intra Aortic Balloon Pump (IABP) is a circulatory mechanical support device, placed in descending aorta, distally from left subclavian artery and proximally from renal artery. IABP works with counterpulsation concept, synchronized with heart cycle.
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 30 days after IABP implantation
Secondary outcomes (1)
All-cause mortality
Measured: 3 months after IABP implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Feb 2012
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
- Investigators
- Yong-feng Shao, MD, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405856
- Sponsor's protocol ID
- IABP-Jsph
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Patients Treated With Intra Aortic Balloon Pump
- ClinicalTrials.gov ID
- NCT04405856
- Acronym / sponsor ID
- IABP-Jsph
- Conditions
- Acute Coronary Syndrome, Cardiogenic Shock, Coronary Artery Disease, Heart Failure, Left Ventricular Dysfunction, Low Cardiac Output Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 May 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.
Intra-Aortic Balloon Pumps (IABP) is a widely used and effective left ventricular adjuvant therapy. IABP is an inflatable device placed in the aorta that inflates with diastole and deflates with systole. The aim of this study is to investigate the outcome of patients treated With IABP, and to evaluate the short-term and long-term outcomes of patients with IABP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving IABP for circulatory support
Key inclusion criteria (1 listed)
- Patients receiving IABP for circulatory support
Key exclusion criteria (1 listed)
- Refusal of consent
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 |
|---|---|---|
| Intra Aortic Balloon PumpIntra Aortic Balloon Pump (IABP) is a circulatory mechanical support device, placed in descending aorta, distally from left subclavian artery and proximally from renal artery. IABP works with counterpulsation concept, synchronized with heart cycle. | Device | – |
Primary outcome
All-cause mortality
Time frame: 30 days after IABP implantation
1 secondary outcome
All-cause mortality
Time frame: 3 months after IABP implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
Yong-feng Shao, MD study director
The First Affiliated Hospital with Nanjing Medical University
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 Coronary Syndrome and Cardiogenic Shock, run by Nanjing Medical University 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 28 May 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 Hong Liu, MD (18801281613, DR.HONGLIU@FOXMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 30 days after IABP implantation). 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 28 May 2020.