Comparing angiography follow-up to clinical follow-up after heart procedures in high-risk patients
Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients (The REVISE Trial)
NA · Second Affiliated Hospital, School of Medicine, Zhejiang University · NCT05923489
This study is trying to see if regular heart imaging check-ups after heart procedures help high-risk patients do better than just regular doctor visits.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2618 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05923489 on ClinicalTrials.gov |
What this trial studies
This study compares the clinical outcomes of routine angiography follow-up versus routine clinical follow-up in patients who have undergone percutaneous coronary intervention (PCI) and are considered high-risk. Eligible participants are those aged 18 and older who have successfully undergone PCI and meet specific high-risk criteria. The study aims to determine if routine angiography follow-up leads to better health outcomes compared to standard clinical follow-up. The interventions being tested are routine angiography follow-up and routine clinical follow-up.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone successful PCI and have at least two high-risk factors.
Not a fit: Patients who have undergone revascularization with bare metal stents or balloon angioplasty with non-drug-coated balloons may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve follow-up care and outcomes for high-risk patients after heart procedures.
How similar studies have performed: Other studies have explored follow-up methods in cardiac patients, but this specific comparison of angiography versus clinical follow-up in high-risk patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years. * Successful PCI with at least two of the following high-risk factors: A. Left main lesion; B. Bifurcation lesion (true bifurcation); C. Ostial lesion of main vessels (left anterior descending, left circumflex artery, right coronary artery); D. Chronic total occlusion; E. Multivessel revascularization (≥ 2 vessels); F. In-stent restenosis; G. Diffuse long lesion (lesion length ≥ 30 mm or stent length ≥ 38 mm); H. Severe calcified lesion (Significant severe calcification on angiography); I. Bypass graft lesion; J. Diabetes mellitus; K. Chronic kidney disease (defined as an estimated glomerular filtration rate of \<30 ml per minute per 1.73 m2 of body-surface area or the receipt of dialysis); L. Myocardial infarction; \- He/she or his/her legally authorized representative provides written informed Exclusion Criteria: * Revascularization with bare metal stents and/or balloon angioplasty with non-drug-coated balloons. * Pregnant and/or lactating women. * Life expectancy of less than 2 years. * Repeat interventional therapy is planned. * Subject was unable to provide written informed consent.
Where this trial is running
Hangzhou, Zhejiang
- The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Jun Jiang, MD, PhD
- Email: jiang-jun@zju.edu.cn
- Phone: +86 0571 87784808
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.
Conditions: Coronary Artery Disease