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

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ClinicalTrials.gov Identifier: NCT02169258
Recruitment Status : Unknown
Verified September 2015 by Ting-Hsing Chao, National Cheng-Kung University Hospital.
Recruitment status was:  Recruiting
First Posted : June 23, 2014
Last Update Posted : September 25, 2015
Sponsor:
Collaborators:
Tainan Municipal Hospital
E-DA Hospital
Kaohsiung Medical University
National Taiwan University Hospital
Buddhist Tzu Chi General Hospital
Far Eastern Memorial Hospital
University of Alberta
Information provided by (Responsible Party):
Ting-Hsing Chao, National Cheng-Kung University Hospital

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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Coronary Artery Disease Procedure: Systemic Strategy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prognostic Impact of ROUtine Coronary CathETerization in Low Extremity ArTEry Disease Undergoing Percutaneous Transluminal Angioplasty (PIROUETTE-PTA Study)
Study Start Date : June 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Routine Coronary Angiography before PTA




Primary Outcome Measures :
  1. Time to Composite of Major Adverse Cardiac Event (MACE) [ Time Frame: up to 48 months ]
    cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization


Secondary Outcome Measures :
  1. MACE between the Screening and 30 days after PTA [ Time Frame: 30 days after indexed PTA ]
    cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization

  2. Time to Composite of major coronary events [ Time Frame: Up to 48 months ]
    fatal or nonfatal myocardial infarction, recurrent angina pectoris, and any unplanned coronary revascularization


Other Outcome Measures:
  1. Time to death from any cause [ Time Frame: Up to 48 months ]
    total mortality

  2. Time to congestive heart failure requiring hospitalization [ Time Frame: Up to 48 months ]
    congestive heart failure requiring hospitalization

  3. Time to any coronary revascularization [ Time Frame: Up to 48 months ]
    planned or unplanned coronary revascularization



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169258


Contacts
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Contact: Ting-Hsing Chao, MD 886-6-2353535 ext 2382 chaoth@mail.ncku.edu.tw

Locations
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Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Ting-Hsing Chao, MD    886-6-2353535 ext 2382    chaoth@mail.ncku.edu.tw   
Principal Investigator: Cheng-Han Lee, MD/PhD         
Sponsors and Collaborators
National Cheng-Kung University Hospital
Tainan Municipal Hospital
E-DA Hospital
Kaohsiung Medical University
National Taiwan University Hospital
Buddhist Tzu Chi General Hospital
Far Eastern Memorial Hospital
University of Alberta
Investigators
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Principal Investigator: Ting-Hsing Chao, MD National Cheng-Kung University Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ting-Hsing Chao, Associate Professor and Attending Physician, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT02169258    
Other Study ID Numbers: B-BR-103-023
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: September 25, 2015
Last Verified: September 2015
Keywords provided by Ting-Hsing Chao, National Cheng-Kung University Hospital:
coronary artery disease
peripheral artery disease
percutaneous transluminal angioplasty
coronary angiography
revascularization
gene polymorphisms
microRNAs
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Peripheral Arterial Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atherosclerosis
Peripheral Vascular Diseases