Clinical trial NCT02169258: Routine Coronary Catheterization in Low Extremity Artery Disease Undergoing Percutaneous Transluminal Angioplasty
Official title: Prognostic Impact of ROUtine Coronary CathETerization in Low Extremity ArTEry Disease Undergoing Percutaneous Transluminal Angioplasty (PIROUETTE-PTA Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Artery Disease
Coronary Artery Disease
Keywords: coronary artery disease
peripheral artery disease
percutaneous transluminal angioplasty
coronary angiography
revascularization
gene polymorphisms
microRNAs
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: Tainan Municipal Hospital
name: E-DA Hospital
name: Kaohsiung Medical University
name: National Taiwan University Hospital
name: Buddhist Tzu Chi General Hospital
name: Far Eastern Memorial Hospital
name: University of Alberta
First posted: 2014-06-23
Enrollment: 700
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. The prevalence of significant and complex obstructive coronary artery disease (CAD) is high in patients who have low extremity artery disease (LEAD).
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.

Detailed description: 1. participants

   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

Eligibility criteria: Inclusion Criteria:

* Known LEAD (documented by previous angiography or sonography performed by the operators) admitted for elective PTA

Exclusion Criteria:

* Known CAD or unstable angina within past 3 months
* 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

Primary outcomes:
measure: Time to Composite of Major Adverse Cardiac Event (MACE)
timeFrame: up to 48 months
Secondary outcomes:
measure: MACE between the Screening and 30 days after PTA
timeFrame: 30 days after indexed PTA
measure: Time to Composite of major coronary events
timeFrame: Up to 48 months
Other outcomes:
measure: Time to death from any cause
timeFrame: Up to 48 months
measure: Time to congestive heart failure requiring hospitalization
timeFrame: Up to 48 months
measure: Time to any coronary revascularization
timeFrame: Up to 48 months
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Ting-Hsing Chao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.