Trials / Unknown
UnknownNCT03372785
The Success of Opening Concurrent CTO leSion to Improve Cardiac Function Trial in Patients With Multi-vessel Disease
The Success of Opening Concurrent Chronic Total Occlusion leSion to Improve Cardiac Function Trial in Patients With Multi-vessel Disease (SOS-moral): Study Protocol of a Prospective Multicenter Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 240 (estimated)
- Sponsor
- Beijing Anzhen Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate the effect of percutaneous coronary intervention (PCI) on cardiac function in multi-vessel disease patients with concurrent chronic total occlusion (CTO) lesion.
Detailed description
Recruited CTO patients will be devided into two groups: those undergoing PCI of only the non-CTO artery (non-CTO PCI group), and those undergoing PCI of the non-CTO artery concurrently with the CTO artery (CTO-PCI group). The primary outcome assessed will be the change in cardiac function evaluated via CMR at a 12-month of follow-up appointment, which will be compared to a baseline measurement. Secondary outcomes include occurrence of major cardiac events, CMR-assessed myocardial viability in the CTO-supplied territory, and quality of life assessed by Seattle angina questionnaire, Patient Health Questionnaire 9 and Generalized Anxiety Disorder Scale-7 after 12-month follow-up.
Conditions
- Chronic Total Occlusion of Coronary Artery
- Percutaneous Coronary Intervention
- Coronary Artery Disease
- Viable Myocardium
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor | Optimal medical therapy includes dual antiplatelet therapy and statins (aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc). And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-anginal therapy should be used if the patients have symptom. |
| DEVICE | coronary wires. stents or coronary balloons | all species of drug-eluting stent ((such as Xience, Endeavor, Resolute) implantation or balloon expansion (POBA) |
Timeline
- Start date
- 2018-04-10
- Primary completion
- 2021-12-01
- Completion
- 2022-04-01
- First posted
- 2017-12-14
- Last updated
- 2020-09-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03372785. Inclusion in this directory is not an endorsement.