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A multicenter, randomized clinical trial in elderly patients (over 80 years old) with unstable angina pectoris or Non-ST elevation myocardial infarction (NSTEMI).
A total of 200 patients will be randomized to medical treatment (100 patients) or coronary angiography with revascularization if feasible (100 patients). Information regarding prior history, frailty, clinical presentation, in-hospital events, complications, angina, quality of life and mortality will be collected. Follow up time is 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative therapy | No Intervention | Optimized medical therapy | |
| Invasive therapy | Experimental | Coronary angiography and revascularization if feasible |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary angiography and revascularization if feasible | Procedure | Coronary angiography and revascularization with PCI or CABG (coronary artery bypass grafting) if feasible |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with major adverse cardiac and cerebral events (the composite of death, myocardial infarction, urgent revascularisation, recurrent hospitalization due to cardiac reason and stroke). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with major bleeding | 1 month | |
| Number of participants with major adverse cardiac or cerebral event | 1 month | |
| Number of participants with minor bleeding |
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Inclusion Criteria:
>80 years of age
Acute coronary syndrome with ischemic symptoms (mainly chest pain) lasting over 10 minutes during the last 72 hours.
AND at least one of the following:
Written informed consent before randomization
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Per A Albertsson, MD, PhD | Contact | +46313421000 | per.albertsson@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Per A Albertsson, PhD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Sahlgrenska University Hospital | Recruiting | Gothenburg | 41345 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32586153 | Derived | Hirlekar G, Libungan B, Karlsson T, Back M, Herlitz J, Albertsson P. Percutaneous coronary intervention in the very elderly with NSTE-ACS: the randomized 80+ study. Scand Cardiovasc J. 2020 Oct;54(5):315-321. doi: 10.1080/14017431.2020.1781243. Epub 2020 Jun 26. | |
| 25189626 | Derived | Libungan B, Hirlekar G, Albertsson P. Coronary angioplasty in octogenarians with emergent coronary syndromes: study protocol for a randomized controlled trial. Trials. 2014 Sep 4;15:349. doi: 10.1186/1745-6215-15-349. |
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| ID | Term |
|---|---|
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D000789 | Angina, Unstable |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| 1 month |
| Number of participants with composite of cardiac death or myocardial infarction | 1 year |
| Change from baseline of participants level of quality of life measured with the SF-36 questionnaire at 12 months | 1 year |
| Change from baseline of participants level of angina pectoris at 12 months | 12 months |
| Number of participants dead (all cause mortality) | 1 year |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D019060 | Minimally Invasive Surgical Procedures |