Routine Coronary Catheterization in Low Extremity Artery Disease Undergoing Percutaneous Transluminal Angioplasty
NCT ID: NCT02169258
Last Updated: 2015-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
700 participants
INTERVENTIONAL
2014-06-30
2018-12-31
Brief Summary
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2. Long-term prognosis of LEAD undergoing percutaneous transluminal angioplasty (PTA) remains poor and CAD is an independent predictor of total mortality after PTA.
3. This prospective randomized controlled trial will evaluate the prognostic effects of routine versus selective coronary angiography before PTA for LEAD and elucidate the potential mechanism.
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Detailed Description
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1. eligible participants are randomly assigned to systemic strategy or selective strategy
* participants allocated to systemic strategy will receive routine coronary angiography before PTA without a previous non-invasive stress test
* subjects allocated to selective strategy will undergo non-invasive evaluation of possible myocardial ischemia by using dobutamine stress echocardiography (DSE) or dipyridamole thallium 201 myocardial perfusion scintigraphy (dTS) followed by coronary angiography if the test is positive for ischemia
2. participants who are not willing to be randomized will be included in the registration group
2. revascularization
1. a staged approach (myocardial revascularization first followed by PTA) and simultaneous approach (percutaneous coronary intervention immediately followed by PTA at the same time if clinically suitable) are both allowed
2. the duration from revascularization to PTA should be within 60 days
3. percutaneous coronary intervention is performed at the time of coronary angiography, using bare metal or drug-eluting stents
3. 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
4. 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Selective Strategy
non-invasive evaluation of possible myocardial ischemia by using DSE or dTS followed by coronary angiography if the test is positive for ischemia
Systemic Strategy
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.
Registry
Clinical decisions are reached by consensus of operators, patients and family as usual care
No interventions assigned to this group
Systemic Strategy
Routine coronary angiography before PTA without a previous non-invasive stress test
Systemic Strategy
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.
Interventions
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Systemic Strategy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Acute myocardial infarction within past 6 months
* Known CAD status posterior percutaneous coronary intervention or bypass surgery within past 6 months
* Planning to do bypass surgery for known LEAD\\
* Pregnancy
* Documented active malignancy
* Needing emergency PTA
20 Years
ALL
No
Sponsors
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Tainan Municipal Hospital
OTHER
E-DA Hospital
OTHER
Kaohsiung Medical University
OTHER
National Taiwan University Hospital
OTHER
Buddhist Tzu Chi General Hospital
OTHER
Far Eastern Memorial Hospital
OTHER
University of Alberta
OTHER
National Cheng-Kung University Hospital
OTHER
Responsible Party
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Ting-Hsing Chao
Associate Professor and Attending Physician
Principal Investigators
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Ting-Hsing Chao, MD
Role: PRINCIPAL_INVESTIGATOR
National Cheng-Kung University Hospital
Locations
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National Cheng Kung University Hospital
Tainan City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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B-BR-103-023
Identifier Type: -
Identifier Source: org_study_id
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