Atrial FibrillationNOAFCAMI-SHNCT03533543
New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction in ShangHai
An observational study of Atrial Fibrillation and Myocardial Infarction, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
To characterize and estimate the incidence rate of new-onset atrial fibrillation (NOAF) in patients with acute myocardial infarction (MI). To explore the prognostic influences of NOAF on MI patients' clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Myocardial Infarction
- What is being tested?
- CEM
- Type of treatment
- Medical device
- How many people
- 2,399 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2018to 13 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute MI without a medical history of AF.
Who may be able to join
- Patients hospitalized for acute MI between February 2014 and March 2018 in the CCU department of Shanghai Tenth People's Hospital;
- Adult patients (>18 years old).
Who cannot join
- Patients with a medical history of pre-existing AF;
- Patietns with a medical histroy of Rheumatic valvular disease;
- Patietns with a medical histroy of sick sinus syndrome;
- Patients undergoing emergent coronary artery bypass surgery;
- Patients' medical records with serious deficiencies and critical information (e.g. demographic data, laboratory testings, etc.) cannot be retrieved;
- Patients who refused to receive electronic monitoring during hospitalization and the data of cardiac rhythm cannot be obtained;
- Premature discharge due to nonmedical reasons such as nonpayment, failure to comply with program rules, conflicting with treatment staff, etc.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Official title: A Retrospective Cohort Study on the Burden of New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction at Shanghai Tenth People's Hospital
To characterize and estimate the incidence rate of new-onset atrial fibrillation (NOAF) in patients with acute myocardial infarction (MI). To explore the prognostic influences of NOAF on MI patients' clinical outcomes. To further investigate the impact of NOAF associated characteristics on patients' clinical outcomes eithier during hospitalization or follow-up period.
Read the detailed description
In the present study, investigators retrospectively reviewed the medical records of all acute MI patients who were admitted to the coronary artery unit (CCU) of Shanghai Tenth People's Hospital between February 2014 and March 2018.
All eligible patients' demographics, cardiovascular risk factors, comorbidities, laboratory tests, echocardiography data, angiography data, acute and dischage medications, and clinical outcomes will be collected. All patients admitt to our CCU department will receive CEM immediately after admission and continue until discharge. Heart thythm status and those characteristics assoicated with NOAF will be reviewed by several independent physicians and recorded in a centralized electronic database.
Several post-MI NOAF assoicated characteristics and definitions are displayed as follows:
- Total CEM duration is defined as the period during which the monitor was started after admission and turned off before discharge.
- AF maintained duration is defined as the period during which an AF episode presented and terminated.
- Total AF duration is calculated by summing all AF episodes' maintained durations descripted above.
- AF burden was calculated by dividing the total AF duration by the total CEM duration.
- NOAF pattern included paroxysmal NOAF, persistent NOAF, transient NOAF, and persisting NOAF, definitions are demonstrated as follows:
- Paroxysmal NOAF is defined as more than 1 episodes of AF occur during hospitalization irrespective of the discharge rhythm status or only 1 episode of AF is observed during hospitalization and maintain sinus rhythm at discharge.
- Persistent NOAF is defined as only 1 episode of AF is observed during hospitalization and maintain AF at discharge.
- Transient NOAF is recorded if AF episodes only occur during hospitalization with emergency department ECG, on-admission ECG and discharge ECG maintaining sinus rhythm, irrespective of the frequencies of AF.
- Persisting NOAF is recorded if AF episodes occur during hospitalization with a discharge ECG still maintaining AF rhythm, irrespective of the frequencies of AF.
- Frequencies of NOAF
- Symptomatic and silent NOAF
- Symptomatic AF is defined as AFresulting in clinical symptoms or the need for urgent cardioversion.
- Silent AF is defined as any asymptomatic episodes of AF lasting for over 30 seconds at CEM.
- Conditions
- Atrial Fibrillation, Myocardial Infarction
- Being tested
- CEM
- Keywords
- Myocardial infarction, New-onset atrial fibrillation, Retrospective, Prognosis
- Medical subject headings
- Atrial Fibrillation, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEMDevice
All patients with MI hospitalized in the CCU department of Shanghai Tenth People's Hospital will receive 24-hour cardiac monitoring until discharge.
| Study group | Role | What they receive |
|---|---|---|
| New-onset atrial fibrillation | Patients with MI who are free from a medical history of atrial fibrillation (AF) will be recognized as NOAF if they develop an atrial fibrillation (lasting for at least 30 seconds which are recorded by CEM) incident during hospitalization. Receives: Device: CEM | |
| Non new-onset atrial fibrillation | Patients with MI who are free from a medical history of AF will be recognized as Non-NOAF if they persist with sinus rhythm (based on CEM) during hospitalization. Receives: Device: CEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac event (MACE)
Cardiovascular death, recurrent myocardial infarction, rehospitalization for heart failure or stroke
Measured: From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years
Secondary outcomes (11)
All-cause death
Death from any cause
Measured: From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years
Cardiovascular death
Death from cardiovascular causes
Measured: From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years
Recurrent myocardial infarction
Rehospitalization for myocardial infarction
Measured: From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years
Rehospitalization for heart failure
Rehospitalization for heart failure
Measured: From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years
Stroke
Stroke is defined as the presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting>24h.
Measured: From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years
In-hospital MACE
Cardiovascular death, nonfatal re-infarction, new congestive heart failure or ischemic stroke at 30 days
Measured: 30 days
In-hospital sustained ventricular tachycardia/ventricular fibrillation
Sustianed ventricular tachycardia is defined as ventricular arrhythemia lasting for over 30s where emergent cardioversion is required. Ventricular fibrillation is defined as the heart quivers instead of pumping due to disorganized electrical activity in the ventricles.
Measured: From the time of admission to coronary care unit until discharge
In-hospital cardiogenic shock
Cardiogenic shock is defined as systolic blood pressure < 90 mmHg not responsive to fluid resuscitation where IV intropes are required.
Measured: From the time of admission to coronary care unit until discharge
Nonfatal re-infarction at 30 days
Re-infarction is defined as recurrent ischemic symptoms> 20 min with new ST elevation> 0.1mV in≥ 2 contiguous leads and was verified by an urgent angiography.
Measured: 30 days
Ischemic stroke at 30 days
Ischemic stroke is defined as the presence of a new focal neurologic deficit thought to be ischemic in origin, with signs or symptoms lasting over 24 hours, which is validated based on a computerized tomography (CT) or magnetic resonance imaging (MRI) examination.
Measured: 30 days
New congestive heart failure at 30 days
New congestive heart failure is defined as the first episode of cardiac decompensation requiring intravenous diuretics when patients suffer chest distress, polypnea or dyspnea.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start20 May 2018
- Primary completion1 Jun 2019
- Study completion13 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yidong Wei, MD, PhD, Principal investigator, Department of Cardiology, Shanghai Tenth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533543
- Sponsor's protocol ID
- NOAFCAMI-SH
- Acronym
- NOAFCAMI-SH
- Status last verified
- Jul 2024
- First submitted
- 28 Apr 2018
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Luo J, Xu S, Li H, Gong M, Li Z, Liu B, Qin X, Shi B, Wei Y. Long-term impact of the burden of new-onset atrial fibrillation in patients with acute myocardial infarction: results from the NOAFCAMI-SH registry. Europace. 2021 Feb 5;23(2):196-204. doi: 10.1093/europace/euaa234.
PubMed 32929491Luo J, Xu S, Li H, Li Z, Liu B, Qin X, Gong M, Shi B, Wei Y. Long-term impact of new-onset atrial fibrillation complicating acute myocardial infarction on heart failure. ESC Heart Fail. 2020 Oct;7(5):2762-2772. doi: 10.1002/ehf2.12872. Epub 2020 Jun 23.
PubMed 32578394Luo J, Liu B, Li H, Xu S, Gong M, Li Z, Qin X, Shi B, Hao C, Zhang J, Wei Y. Prognostic Impact of the Symptom of New-Onset Atrial Fibrillation in Acute Myocardial Infarction: Insights From the NOAFCAMI-SH Registry. Front Cardiovasc Med. 2021 Sep 22;8:677695. doi: 10.3389/fcvm.2021.677695. eCollection 2021.
PubMed 34631808Hao C, Luo J, Liu B, Xu W, Li Z, Gong M, Qin X, Shi B, Wei Y. Prognostic Significance of New-Onset Atrial Fibrillation in Heart Failure with Preserved, Mid-Range, and Reduced Ejection Fraction Following Acute Myocardial Infarction: Data from the NOAFCAMI-SH Registry. Clin Interv Aging. 2022 Apr 13;17:479-493. doi: 10.2147/CIA.S358349. eCollection 2022.
PubMed 35444413Luo J, Xu S, Li H, Li Z, Gong M, Qin X, Zhang X, Hao C, Liu X, Zhang W, Xu W, Liu B, Wei Y. Prognostic impact of stress hyperglycemia ratio in acute myocardial infarction patients with and without diabetes mellitus. Nutr Metab Cardiovasc Dis. 2022 Oct;32(10):2356-2366. doi: 10.1016/j.numecd.2022.07.004. Epub 2022 Jul 16.
PubMed 35965248Luo J, Li Z, Qin X, Zhang X, Liu X, Zhang W, Xu W, Zhang Y, Fang Y, Liu B, Wei Y; NOAFCAMI-SH Registry Investigators. Prognostic implications of the 4S-AF scheme to characterize new-onset atrial fibrillation after myocardial infarction. Eur J Intern Med. 2023 Jul;113:38-44. doi: 10.1016/j.ejim.2023.04.003. Epub 2023 Apr 8.
PubMed 37037721Luo J, Li Z, Qin X, Zhang X, Liu X, Zhang W, Xu W, Liu B, Wei Y; NOAFCAMI-SH Registry Investigators. Association of stress hyperglycemia ratio with in-hospital new-onset atrial fibrillation and long-term outcomes in patients with acute myocardial infarction. Diabetes Metab Res Rev. 2024 Feb;40(2):e3726. doi: 10.1002/dmrr.3726. Epub 2023 Sep 15.
PubMed 37712510Luo J, Qin X, Zhang X, Zhang Y, Yuan F, Shi W, Liu B, Wei Y; NOAFCAMI-SH Registry Investigators. Prognostic implications of systemic immune-inflammation index in myocardial infarction patients with and without diabetes: insights from the NOAFCAMI-SH registry. Cardiovasc Diabetol. 2024 Jan 22;23(1):41. doi: 10.1186/s12933-024-02129-x.
PubMed 38254086Luo J, Qin X, Zhang X, Zhang Y, Fang Y, Shi W, Liu B, Wei Y; NOAFCAMI-SH Registry Investigators. Prognostic impact of new-onset atrial fibrillation in myocardial infarction with and without improved ejection fraction. ESC Heart Fail. 2024 Dec;11(6):3713-3722. doi: 10.1002/ehf2.14956. Epub 2024 Jul 10.
PubMed 38984376
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study on the Burden of New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction at Shanghai Tenth People's Hospital
- ClinicalTrials.gov ID
- NCT03533543
- Acronym / sponsor ID
- NOAFCAMI-SH / NOAFCAMI-SH
- Conditions
- Atrial Fibrillation, Myocardial Infarction
- Keywords
- Myocardial infarction, New-onset atrial fibrillation, Retrospective, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,399 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 20 May 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 13 Sep 2019 (actual)
- First posted
- 23 May 2018 (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.
To characterize and estimate the incidence rate of new-onset atrial fibrillation (NOAF) in patients with acute myocardial infarction (MI). To explore the prognostic influences of NOAF on MI patients' clinical outcomes. To further investigate the impact of NOAF associated characteristics on patients' clinical outcomes eithier during hospitalization or follow-up period.
Detailed description
In the present study, investigators retrospectively reviewed the medical records of all acute MI patients who were admitted to the coronary artery unit (CCU) of Shanghai Tenth People's Hospital between February 2014 and March 2018.
All eligible patients' demographics, cardiovascular risk factors, comorbidities, laboratory tests, echocardiography data, angiography data, acute and dischage medications, and clinical outcomes will be collected. All patients admitt to our CCU department will receive CEM immediately after admission and continue until discharge. Heart thythm status and those characteristics assoicated with NOAF will be reviewed by several independent physicians and recorded in a centralized electronic database.
Several post-MI NOAF assoicated characteristics and definitions are displayed as follows:
- Total CEM duration is defined as the period during which the monitor was started after admission and turned off before discharge.
- AF maintained duration is defined as the period during which an AF episode presented and terminated.
- Total AF duration is calculated by summing all AF episodes' maintained durations descripted above.
- AF burden was calculated by dividing the total AF duration by the total CEM duration.
- NOAF pattern included paroxysmal NOAF, persistent NOAF, transient NOAF, and persisting NOAF, definitions are demonstrated as follows:
- Paroxysmal NOAF is defined as more than 1 episodes of AF occur during hospitalization irrespective of the discharge rhythm status or only 1 episode of AF is observed during hospitalization and maintain sinus rhythm at discharge.
- Persistent NOAF is defined as only 1 episode of AF is observed during hospitalization and maintain AF at discharge.
- Transient NOAF is recorded if AF episodes only occur during hospitalization with emergency department ECG, on-admission ECG and discharge ECG maintaining sinus rhythm, irrespective of the frequencies of AF.
- Persisting NOAF is recorded if AF episodes occur during hospitalization with a discharge ECG still maintaining AF rhythm, irrespective of the frequencies of AF.
- Frequencies of NOAF
- Symptomatic and silent NOAF
- Symptomatic AF is defined as AFresulting in clinical symptoms or the need for urgent cardioversion.
- Silent AF is defined as any asymptomatic episodes of AF lasting for over 30 seconds at CEM.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New-onset atrial fibrillation | – | Device: CEMPatients with MI who are free from a medical history of atrial fibrillation (AF) will be recognized as NOAF if they develop an atrial fibrillation (lasting for at least 30 seconds which are recorded by CEM) incident during hospitalization. |
| Non new-onset atrial fibrillation | – | Device: CEMPatients with MI who are free from a medical history of AF will be recognized as Non-NOAF if they persist with sinus rhythm (based on CEM) during hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute MI without a medical history of AF.
Key inclusion criteria (2 listed)
- Patients hospitalized for acute MI between February 2014 and March 2018 in the CCU department of Shanghai Tenth People's Hospital;
- Adult patients (>18 years old).
Key exclusion criteria (7 listed)
- Patients with a medical history of pre-existing AF;
- Patietns with a medical histroy of Rheumatic valvular disease;
- Patietns with a medical histroy of sick sinus syndrome;
- Patients undergoing emergent coronary artery bypass surgery;
- Patients' medical records with serious deficiencies and critical information (e.g. demographic data, laboratory testings, etc.) cannot be retrieved;
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 |
|---|---|---|
| CEMAll patients with MI hospitalized in the CCU department of Shanghai Tenth People's Hospital will receive 24-hour cardiac monitoring until discharge. | Device | New-onset atrial fibrillation, Non new-onset atrial fibrillation |
Primary outcome
Major adverse cardiac event (MACE)
Time frame: From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years
Cardiovascular death, recurrent myocardial infarction, rehospitalization for heart failure or stroke
11 secondary outcomes
All-cause death
Time frame: From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years
Cardiovascular death
Time frame: From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years
Recurrent myocardial infarction
Time frame: From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years
Rehospitalization for heart failure
Time frame: From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years
Stroke
Time frame: From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years
In-hospital MACE
Time frame: 30 days
In-hospital sustained ventricular tachycardia/ventricular fibrillation
Time frame: From the time of admission to coronary care unit until discharge
In-hospital cardiogenic shock
Time frame: From the time of admission to coronary care unit until discharge
Nonfatal re-infarction at 30 days
Time frame: 30 days
Ischemic stroke at 30 days
Time frame: 30 days
New congestive heart failure at 30 days
Time frame: 30 days
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 16 Jul 2024.
- Results publication: PubMed 32929491Luo J, Xu S, Li H, Gong M, Li Z, Liu B, Qin X, Shi B, Wei Y. Long-term impact of the burden of new-onset atrial fibrillation in patients with acute myocardial infarction: results from the NOAFCAMI-SH registry. Europace. 2021 Feb 5;23(2):196-204. doi: 10.1093/europace/euaa234.
- Results publication: PubMed 32578394Luo J, Xu S, Li H, Li Z, Liu B, Qin X, Gong M, Shi B, Wei Y. Long-term impact of new-onset atrial fibrillation complicating acute myocardial infarction on heart failure. ESC Heart Fail. 2020 Oct;7(5):2762-2772. doi: 10.1002/ehf2.12872. Epub 2020 Jun 23.
- Results publication: PubMed 34631808Luo J, Liu B, Li H, Xu S, Gong M, Li Z, Qin X, Shi B, Hao C, Zhang J, Wei Y. Prognostic Impact of the Symptom of New-Onset Atrial Fibrillation in Acute Myocardial Infarction: Insights From the NOAFCAMI-SH Registry. Front Cardiovasc Med. 2021 Sep 22;8:677695. doi: 10.3389/fcvm.2021.677695. eCollection 2021.
- Results publication: PubMed 35444413Hao C, Luo J, Liu B, Xu W, Li Z, Gong M, Qin X, Shi B, Wei Y. Prognostic Significance of New-Onset Atrial Fibrillation in Heart Failure with Preserved, Mid-Range, and Reduced Ejection Fraction Following Acute Myocardial Infarction: Data from the NOAFCAMI-SH Registry. Clin Interv Aging. 2022 Apr 13;17:479-493. doi: 10.2147/CIA.S358349. eCollection 2022.
- Results publication: PubMed 35965248Luo J, Xu S, Li H, Li Z, Gong M, Qin X, Zhang X, Hao C, Liu X, Zhang W, Xu W, Liu B, Wei Y. Prognostic impact of stress hyperglycemia ratio in acute myocardial infarction patients with and without diabetes mellitus. Nutr Metab Cardiovasc Dis. 2022 Oct;32(10):2356-2366. doi: 10.1016/j.numecd.2022.07.004. Epub 2022 Jul 16.
- Results publication: PubMed 37037721Luo J, Li Z, Qin X, Zhang X, Liu X, Zhang W, Xu W, Zhang Y, Fang Y, Liu B, Wei Y; NOAFCAMI-SH Registry Investigators. Prognostic implications of the 4S-AF scheme to characterize new-onset atrial fibrillation after myocardial infarction. Eur J Intern Med. 2023 Jul;113:38-44. doi: 10.1016/j.ejim.2023.04.003. Epub 2023 Apr 8.
- Results publication: PubMed 37712510Luo J, Li Z, Qin X, Zhang X, Liu X, Zhang W, Xu W, Liu B, Wei Y; NOAFCAMI-SH Registry Investigators. Association of stress hyperglycemia ratio with in-hospital new-onset atrial fibrillation and long-term outcomes in patients with acute myocardial infarction. Diabetes Metab Res Rev. 2024 Feb;40(2):e3726. doi: 10.1002/dmrr.3726. Epub 2023 Sep 15.
- Results publication: PubMed 38254086Luo J, Qin X, Zhang X, Zhang Y, Yuan F, Shi W, Liu B, Wei Y; NOAFCAMI-SH Registry Investigators. Prognostic implications of systemic immune-inflammation index in myocardial infarction patients with and without diabetes: insights from the NOAFCAMI-SH registry. Cardiovasc Diabetol. 2024 Jan 22;23(1):41. doi: 10.1186/s12933-024-02129-x.
- Results publication: PubMed 38984376Luo J, Qin X, Zhang X, Zhang Y, Fang Y, Shi W, Liu B, Wei Y; NOAFCAMI-SH Registry Investigators. Prognostic impact of new-onset atrial fibrillation in myocardial infarction with and without improved ejection fraction. ESC Heart Fail. 2024 Dec;11(6):3713-3722. doi: 10.1002/ehf2.14956. Epub 2024 Jul 10.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
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.
Yidong Wei, MD, PhD principal investigator
Department of Cardiology, Shanghai Tenth People's 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 Atrial Fibrillation and Myocardial Infarction, run by Shanghai 10th People's 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 2 inclusion and 7 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 16 Jul 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?
Major adverse cardiac event (MACE) (time frame: From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years). 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 NCT03533543, which also lists 9 linked publications.
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 16 Jul 2024.