New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction in ShangHai

NCT03533543 | Completed DMC

• 1 other identifier: NOAFCAMI-SH
• Study Type: observational
• Target: 2,399
• Locations: 1 country
• Sites: 1

Brief 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. To further investigate the impact of NOAF associated characteristics on patients' clinical outcomes eithier during hospitalization or follow-up period.

Conditions

Atrial Fibrillation; Myocardial Infarction

Keywords

Myocardial infarction; New-onset atrial fibrillation; Retrospective; Prognosis

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac event (MACE)

  Cardiovascular death, recurrent myocardial infarction, rehospitalization for heart failure or stroke

  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

  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

  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

  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

  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

  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

Study Arms (2)

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.

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.

Device: CEM

Interventions

CEM DEVICE

All patients with MI hospitalized in the CCU department of Shanghai Tenth People's Hospital will receive 24-hour cardiac monitoring until discharge.

New-onset atrial fibrillation; Non new-onset atrial fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute MI without a medical history of AF.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (9)

• 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.

  PMID: 32929491 RESULT

• Luo 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.

  PMID: 32578394 RESULT

• Luo 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.

  PMID: 34631808 RESULT

• Hao 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.

  PMID: 35444413 RESULT

• Luo 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.

  PMID: 35965248 RESULT

• Luo 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.

  PMID: 37037721 RESULT

• Luo 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.

  PMID: 37712510 RESULT

• Luo 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.

  PMID: 38254086 RESULT

• Luo 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.

  PMID: 38984376 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Myocardial Infarction

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis

Study Officials

• Yidong Wei, MD, PhD

  Department of Cardiology, Shanghai Tenth People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 28, 2018
• First Posted: May 23, 2018
• Study Start: May 20, 2018
• Primary Completion: June 1, 2019
• Study Completion: September 13, 2019
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

CN (1)