Intervention for heart attack patients with gum disease
Oral Health Intervention Study in Patients with Myocardial Infarction and Periodontal Disease: a Simulated RCT Trial
This study tests if treating gum disease with surgery can help heart attack patients feel better and improve their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Shanghai 10th People's Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06745141 on ClinicalTrials.gov |
What this trial studies
This study aims to create a shared database of patients who have experienced acute myocardial infarction and also suffer from periodontitis. It will evaluate the clinical benefits of periodontal interventions, specifically periodontal surgery, on these patients. By simulating a randomized controlled trial, the study seeks to promote the integration of oral health interventions into clinical practice for heart attack patients. The ultimate goal is to clarify the relationship between periodontal health and outcomes in myocardial infarction cases.
Who should consider this trial
Good fit: Ideal candidates are patients aged 30 and older who have been diagnosed with ST-segment elevation myocardial infarction and have severe periodontal disease.
Not a fit: Patients under 30 years old or those with significant health issues such as HIV, chronic inflammation, or significant tooth loss may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve recovery outcomes for heart attack patients with periodontal disease through targeted oral health interventions.
How similar studies have performed: While the specific approach of this study may be novel, there is growing interest in the link between oral health and cardiovascular outcomes, suggesting potential for success based on related research.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Tenth People's Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jiawen Wu
- Email: chloewuu@foxmail.com
- Phone: 86+17717070557
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.