Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tainan Municipal Hospital | OTHER |
| E-DA Hospital | OTHER |
| Kaohsiung Medical University | OTHER |
| National Taiwan University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
participants
eligible participants are randomly assigned to systemic strategy or selective strategy
participants who are not willing to be randomized will be included in the registration group
revascularization
blood sampling, genotyping, and measurement of biomarkers and microRNA
a. bood samples (20 mL) are obtained from peripheral arteries in all study subjects before PTA and 10 mL after PTA and are prepared and stored for enzyme-linked immunosorbent assay (ELISA), genotyping and measurement of microRNAs in plasma and peripheral blood mononuclear cells
outcome follow-up a. clinical outcomes are obtained by chart review if the patient is still in the hospital and followed up by clinic visit, telephone call or direct contact with participants or subjects' family at 30 days after indexed PTA if the patient has been discharged from the hospital and every 6 months thereafter
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selective Strategy | Placebo Comparator | non-invasive evaluation of possible myocardial ischemia by using DSE or dTS followed by coronary angiography if the test is positive for ischemia |
|
| Registry | No Intervention | Clinical decisions are reached by consensus of operators, patients and family as usual care | |
| Systemic Strategy | Active Comparator | Routine coronary angiography before PTA without a previous non-invasive stress test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systemic Strategy | Procedure | Significant CAD needing further revascularization is defined as patients who have luminal stenosis > 70% of the major epicardial vessels and bypass graft vessel or their major branches (> 50% for left main trunk or in-stent restenotic lesion) with reference vessel larger than 2.5 mm in diameter and moderate area of vulnerable myocardium for ischemia. Intermediate stenotic lesions should be determined if they are hemodynamic significant by fractional flow reserve (FFR) (<=0.8). The choice of revascularization procedure, either percutaneous coronary intervention or coronary artery bypass surgery, depends on operator's or cardiovascular team's suggestion and patient's decision. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Composite of Major Adverse Cardiac Event (MACE) | cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization | up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| MACE between the Screening and 30 days after PTA | cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization | 30 days after indexed PTA |
| Time to Composite of major coronary events |
| Measure | Description | Time Frame |
|---|---|---|
| Time to death from any cause | total mortality | Up to 48 months |
| Time to congestive heart failure requiring hospitalization | congestive heart failure requiring hospitalization |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting-Hsing Chao, MD | Contact | 886-6-2353535 | 2382 | chaoth@mail.ncku.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Ting-Hsing Chao, MD | National Cheng-Kung University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Recruiting | Tainan | 704 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24357434 | Background | Chang SH, Tsai YJ, Chou HH, Wu TY, Hsieh CA, Cheng ST, Huang HL. Clinical predictors of long-term outcomes in patients with critical limb ischemia who have undergone endovascular therapy. Angiology. 2014 Apr;65(4):315-22. doi: 10.1177/0003319713515544. Epub 2013 Dec 19. | |
| 19729114 | Background | Monaco M, Stassano P, Di Tommaso L, Pepino P, Giordano A, Pinna GB, Iannelli G, Ambrosio G. Systematic strategy of prophylactic coronary angiography improves long-term outcome after major vascular surgery in medium- to high-risk patients: a prospective, randomized study. J Am Coll Cardiol. 2009 Sep 8;54(11):989-96. doi: 10.1016/j.jacc.2009.05.041. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| OTHER |
| Buddhist Tzu Chi General Hospital | OTHER |
| Far Eastern Memorial Hospital | OTHER |
| University of Alberta | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
fatal or nonfatal myocardial infarction, recurrent angina pectoris, and any unplanned coronary revascularization
| Up to 48 months |
| Up to 48 months |
| Time to any coronary revascularization | planned or unplanned coronary revascularization | Up to 48 months |
| 20207271 | Background | Duran NE, Duran I, Gurel E, Gunduz S, Gol G, Biteker M, Ozkan M. Coronary artery disease in patients with peripheral artery disease. Heart Lung. 2010 Mar-Apr;39(2):116-20. doi: 10.1016/j.hrtlng.2009.07.004. |
| 26927298 | Derived | Chen IC, Lee CH, Chao TH, Tseng WK, Lin TH, Chung WJ, Li JK, Huang HL, Liu PY, Chao TK, Chu CY, Lin CC, Hsu PC, Lee WH, Lee PT, Li YH, Tseng SY, Tsai LM, Hwang JJ. Impact of routine coronary catheterization in low extremity artery disease undergoing percutaneous transluminal angioplasty: study protocol for a multi-center randomized controlled trial. Trials. 2016 Feb 29;17(1):112. doi: 10.1186/s13063-016-1237-0. |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |