Acute Myocardial InfarctionSTIMULATENCT06186713
Pulmonary Hypertension on Prognosis of Acute Myocardial Infarction Patients With Reduced Left Ventricular Function
An observational study of Acute Myocardial Infarction and Pulmonary Hypertension, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Pulmonary hypertension (PH) has a negative effect on acute myocardial infarction (AMI) patients and appears to be closely associated with reduced left ventricular function. However, its impact on AMI patients with reduced left ventricular function remains unclear. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocardial Infarction, Pulmonary Hypertension
- How many people
- 4,784 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2023to 1 Aug 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This retrospective cohort study included patients who were hospitalized for AMI with reduced left ventricular function at the First Affiliated Hospital of Jiaotong University from January 2018 to January 2022.
Who may be able to join
- The patients who were hospitalized for AMI with reduced left ventricular function at the First Affiliated Hospital of Jiaotong University from January 2018 to January 2022.
Who cannot join
- Myocardial infarction complicated by cardiac rupture.
- Significant pre-existing heart failure.
- Other comorbidities such as malignancy that may significantly affect prognosis.
- Incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: Pulmonary Hypertension on Prognosis of Acute Myocardial Infarction Patients With Reduced Left Ventricular Function (STIMULATE): A Single-center, Retrospective Cohort Study
Pulmonary hypertension (PH) has a negative effect on acute myocardial infarction (AMI) patients and appears to be closely associated with reduced left ventricular function. However, its impact on AMI patients with reduced left ventricular function remains unclear. This retrospective study included AMI patients with reduced left ventricular function to investigate the prognostic value of PH in this specific type of patient. Meanwhile, a nomogram would be established basing on the identified independent risk factors, hoping to provide a novel risk stratification for them.
- Being tested
- This was an observational study, and no Intervention was given to the patients.
- Keywords
- Acute Myocardial Infarction, Pulmonary Hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This was an observational study, and no Intervention was given to the patients.Other
This was an observational study, and no Intervention was given to the patients.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary hypertension (PH) group | The PH group comprised of patients with systolic pulmonary artery pressure (sPAP) ≥ 35mmHg measured by echocardiology. Receives: Other: This was an observational study, and no Intervention was given to the patients. | |
| Control group | The control group included patients with systolic pulmonary artery pressure (sPAP) <35mmHg measured by echocardiology. Receives: Other: This was an observational study, and no Intervention was given to the patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of all-cause death
All-cause death will be determined by clinical records or phone calls with patients and their family.
Measured: 1-year after the AMI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start30 Mar 2023
- Primary completion31 Jul 2023
- Study completion1 Aug 2023
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 Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- Retrospective
- Enrolment
- 4,784 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang Yan, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186713
- Sponsor's protocol ID
- XJTU1AF2023LSK-406
- Acronym
- STIMULATE
- Status last verified
- Dec 2023
- First submitted
- 6 Jul 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Q, Zhao C, Dang P, Li Y, Yan Y. Prognostic value of pulmonary hypertension with a nomogram in acute myocardial infarction patients with reduced left ventricular function. Front Cardiovasc Med. 2024 Apr 22;11:1368139. doi: 10.3389/fcvm.2024.1368139. eCollection 2024.
PubMed 38711791
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Hypertension on Prognosis of Acute Myocardial Infarction Patients With Reduced Left Ventricular Function (STIMULATE): A Single-center, Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06186713
- Acronym / sponsor ID
- STIMULATE / XJTU1AF2023LSK-406
- Keywords
- Acute Myocardial Infarction, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,784 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 2 Jan 2024 (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.
Pulmonary hypertension (PH) has a negative effect on acute myocardial infarction (AMI) patients and appears to be closely associated with reduced left ventricular function. However, its impact on AMI patients with reduced left ventricular function remains unclear. This retrospective study included AMI patients with reduced left ventricular function to investigate the prognostic value of PH in this specific type of patient. Meanwhile, a nomogram would be established basing on the identified independent risk factors, hoping to provide a novel risk stratification for them.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary hypertension (PH) group | – | Other: This was an observational study, and no Intervention was given to the patients.The PH group comprised of patients with systolic pulmonary artery pressure (sPAP) ≥ 35mmHg measured by echocardiology. |
| Control group | – | Other: This was an observational study, and no Intervention was given to the patients.The control group included patients with systolic pulmonary artery pressure (sPAP) <35mmHg measured by echocardiology. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective cohort study included patients who were hospitalized for AMI with reduced left ventricular function at the First Affiliated Hospital of Jiaotong University from January 2018 to January 2022.
Key inclusion criteria (1 listed)
- The patients who were hospitalized for AMI with reduced left ventricular function at the First Affiliated Hospital of Jiaotong University from January 2018 to January 2022.
Key exclusion criteria (4 listed)
- Myocardial infarction complicated by cardiac rupture.
- Significant pre-existing heart failure.
- Other comorbidities such as malignancy that may significantly affect prognosis.
- Incomplete clinical data.
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 |
|---|---|---|
| This was an observational study, and no Intervention was given to the patients.This was an observational study, and no Intervention was given to the patients. | Other | Control group, Pulmonary hypertension (PH) group |
Primary outcome
The incidence of all-cause death
Time frame: 1-year after the AMI.
All-cause death will be determined by clinical records or phone calls with patients and their family.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Derived from this study: PubMed 38711791Liu Q, Zhao C, Dang P, Li Y, Yan Y. Prognostic value of pulmonary hypertension with a nomogram in acute myocardial infarction patients with reduced left ventricular function. Front Cardiovasc Med. 2024 Apr 22;11:1368139. doi: 10.3389/fcvm.2024.1368139. eCollection 2024.
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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.
Yang Yan principal investigator
First Affiliated Hospital Xi'an Jiaotong 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 Myocardial Infarction and Pulmonary Hypertension, run by First Affiliated Hospital Xi'an Jiaotong 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 4 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: finished, as of the sponsor's last update on 2 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of all-cause death (time frame: 1-year after the AMI.). 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 NCT06186713, 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 2 Jan 2024.