Routine Coronary Catheterization in Low Extremity Artery Disease Undergoing Percutaneous Transluminal Angioplasty (PIROUETTEPTA)

Prognostic Impact of ROUtine Coronary CathETerization in Low Extremity ArTEry Disease Undergoing Percutaneous Transluminal Angioplasty (PIROUETTE-PTA Study)

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Peripheral Artery Disease
• Intervention / Treatment: Procedure: Systemic Strategy

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

• Study Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • Recruiting
    • National Cheng Kung University Hospital
    • Contact: Ting-Hsing Chao, MD; Phone Number: 2382 886-6-2353535; Email: chaoth@mail.ncku.edu.tw
    • Principal Investigator: Cheng-Han Lee, MD/PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Procedure: 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 Names: Routine Coronary Angiography before PTA
No Intervention: Registry; Clinical decisions are reached by consensus of operators, patients and family as usual care
Active Comparator: Systemic Strategy; Routine coronary angiography before PTA without a previous non-invasive stress test	Procedure: 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 Names: Routine Coronary Angiography before PTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	fatal or nonfatal myocardial infarction, recurrent angina pectoris, and any unplanned coronary revascularization	Up to 48 months

Other Outcome Measures

Outcome Measure	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	Up to 48 months
Time to any coronary revascularization	planned or unplanned coronary revascularization	Up to 48 months

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Collaborators: National Taiwan University Hospital; University of Alberta; Buddhist Tzu Chi General Hospital; Far Eastern Memorial Hospital; Tainan Municipal Hospital; Kaohsiung Medical University; E-DA Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: June 19, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Estimate): September 25, 2015
• Last Update Submitted That Met QC Criteria: September 23, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: microRNAs; coronary artery disease; peripheral artery disease; revascularization; coronary angiography; percutaneous transluminal angioplasty; gene polymorphisms
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Peripheral Arterial Disease
• Other Study ID Numbers: B-BR-103-023