Myocardial Infarction and Periodontitis: Periodontal Health Intervention.

Not Applicable

Recruiting

• Conditions: Acute Myocardial Infarction (AMI); Periodontal Disease

• Registration Number: NCT06745141
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

The aim of this study is to establish a shared database of acute myocardial infarction patients with periodontitis, to clarify the clinical benefits of periodontitis intervention on acute myocardial infarction patients through simulated RCT study, and to establish a high-level database of acute myocardial infarction patients with periodontitis, so as to promote the application of oral health intervention in clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1)Patients diagnosed with ST-segment elevation myocardial infarction (STEMI). 2)Patients with severe periodontal disease, defined as:

  • 5 teeth with clinical attachment loss (CAL) ≥ 4 mm.

    • Subgingival probing depth (PD) ≥ 6 mm. ③≥ 8 teeth with gingival bleeding on probing (BOP). 3）Age ≥30 years. 4）Written informed consent provided.

Exclusion Criteria

• 1. under 30 years old; 2) HIV positive, chronic inflammation, tumor disease, drug dependence, use of anticonvulsants, use of immunosuppressive agents, pregnancy, and lactation; 3) significant tooth loss (number of remaining teeth < 8); 4) long hospital stay (>10 days), new myocardial infarction before randomization, and stent thrombosis; 5) Refusal to sign informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in ejection fraction	From enrollment to the end of treatment at 6 months	The ejection fraction (EF) changed by 10% half a year after surgery

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death and MACE events were recorded	From enrollment to the end of treatment at 6 months, a maximum of 12 months.
level of proBNP	From enrollment to the end of treatment at 6 months	The outcome will be assessed by measuring the level of plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP), a biomarker reflecting cardiac stress and heart failure.

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China