National registry of rapid unexplained coronary in‑stent restenosis (RECUR)
National Multicenter Cohort Registry Study of Rapid rEcurrences of Coronary Unexplained In-stent Restenosis
This nationwide registry will collect clinical and test data to see if patterns or biomarkers link to rapid unexplained in‑stent restenosis in adults with coronary stents.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05437965 on ClinicalTrials.gov |
What this trial studies
This is a national, multicenter observational cohort registry enrolling adults with rapid recurrences of unexplained coronary in‑stent restenosis (RECUR). Participating centers will collect standardized clinical data, imaging, laboratory biomarkers, treatment details, and follow‑up outcomes while patients receive usual care from experienced clinicians. The project aims to build a diagnostic assessment framework and enable longitudinal analyses to identify patterns, risk factors, and potential biomarkers associated with rapid unexplained restenosis. Data will be centrally managed and analyzed to inform diagnostic criteria and guide future interventional research.
Who should consider this trial
Good fit: Adults aged 18 or older who meet diagnostic criteria for RECUR, can provide informed consent, and are able to attend follow‑up at participating centers are ideal candidates.
Not a fit: Patients with known autoimmune or rheumatic vasculitis, variant angina, coronary dissection, thrombophilia, stent underexpansion, severe comorbidities limiting life expectancy <12 months, psychiatric disorders, or inability to complete follow‑up are unlikely to benefit from inclusion.
Why it matters
Potential benefit: If successful, the registry could help identify causes or biomarkers of rapid in‑stent restenosis and improve diagnosis and treatment strategies to reduce repeat events.
How similar studies have performed: Previous multicenter registries and biomarker studies of in‑stent restenosis have identified risk factors and inflammatory markers, but focused registries on rapid unexplained recurrences are relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Age ≥ 18 years;
2. Patients meeting the diagnostic criteria for Rapid rEcurrences of Coronary Unexplained in-stent Restenosis (RECUR);
3. Patients fully informed about the trial procedures who provide written informed consent.
Exclusion Criteria:
1. Patients presenting with any of the following:
* Other severe comorbidities (e.g., malignant tumors, heart failure) with a life expectancy \<12 months;
* Known autoimmune/rheumatic diseases including systemic lupus erythematosus, Takayasu arteritis, Behçet's disease, polyarteritis nodosa, Wegener granulomatosis (granulomatosis with polyangiitis), eosinophilic arteritis, giant cell arteritis, rheumatoid arthritis, or IgG4-related disease;
* Variant angina (Prinzmetal's angina);
* Coronary artery dissection;
* Thrombophilia;
* Stent underexpansion.
2. Presence of psychiatric disorders;
3. Known inability to complete expected study follow-up for any reason;
4. Patients deemed ineligible for enrollment by the investigator.
Where this trial is running
Beijing, Beijing Municipality
- Jia Lei — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Hong Jian Wang, Dr.
- Email: hongjian.wang@gmail.com
- Phone: 008613910008985
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.