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Randomized registry for the study of CTO PCI as adjunction to optimal medical therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial conservative treatment | Active Comparator | Optimal medical therapy and option for crossover after 6 months or fulfillment of certain conditions |
|
| initial interventional treatment | Experimental | CTO PCI attempt as initial strategy with medical optimization simultaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTO PCI | Procedure | attempted percutaneous coronary intervention of the chronic total coronary occlusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality after inclusion of 2000 patients | a minimal follow-up of 6 months |
| Quality of life assessment | Quality of life assessment by 12-Item Short Form Survey Instrument (SF-12v2) | 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| MR perfusion | Reduction of inducible myocardial perfusion defect evaluated, improvement of left ventricular function and correlation of angina and perfusion defect | 6 months |
| Echocardiography | evaluation of systolic and diastolic left ventricular function compared to index echocardiography before CTO PCI. |
| Measure | Description | Time Frame |
|---|---|---|
| Socio-economic | Socio-economic consequenses of CTO PCI. Treatment cost compared to coronary bypass surgery | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Søren Pihlkjær Hjortshøj, MD | Aalborg University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | 9100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37117085 | Derived | Christensen MK, Eftekhari A, Raungaard B, Steigen TK, Kumsaars I, Riahi S, Sogaard P, Thuesen L. Impact of Percutaneous Intervention Compared to Pharmaceutical Therapy on Complex Arrhythmias in Patients With Chronic Total Coronary Occlusion. Rationale and Design of the CTO-ARRHYTHMIA Study. Cardiovasc Revasc Med. 2023 Sep;54:69-72. doi: 10.1016/j.carrev.2023.04.001. Epub 2023 Apr 10. | |
| 34238552 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2018 | Jun 1, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
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Randomized registry with option of crossover after 6months
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| 6 months |
| Derived |
| Rinfret S, Sandesara PB. Reducing Ischemia With CTO PCI: Good News, But Questions Remain. JACC Cardiovasc Interv. 2021 Jul 12;14(13):1419-1422. doi: 10.1016/j.jcin.2021.05.028. No abstract available. |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |