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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

Tracking Information
First Submitted Date  ICMJE June 19, 2014
First Posted Date  ICMJE June 23, 2014
Last Update Posted Date September 25, 2015
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2014)
Time to Composite Major Adverse Cardiac Event (MACE) [ Time Frame: up to 48 months ]
cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and target vessel revascularization
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2015)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2014)
MACE between the Screening and 30 days after PTA [ Time Frame: 30 days after indexed PTA ]
cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and target vessel revascularization
Current Other Pre-specified Outcome Measures
 (submitted: September 23, 2015)
  • Time to death from any cause [ Time Frame: Up to 48 months ]
    total mortality
  • Time to congestive heart failure requiring hospitalization [ Time Frame: Up to 48 months ]
    congestive heart failure requiring hospitalization
  • Time to any coronary revascularization [ Time Frame: Up to 48 months ]
    planned or unplanned coronary revascularization
Original Other Pre-specified Outcome Measures
 (submitted: June 20, 2014)
Time to Composite Major Coronary Event [ Time Frame: Up to 48 months ]
fatal or nonfatal myocardial infarction, recurrent angina pectoris, and target vessel revascularization
 
Descriptive Information
Brief Title  ICMJE Routine Coronary Catheterization in Low Extremity Artery Disease Undergoing Percutaneous Transluminal Angioplasty
Official Title  ICMJE Prognostic Impact of ROUtine Coronary CathETerization in Low Extremity ArTEry Disease Undergoing Percutaneous Transluminal Angioplasty (PIROUETTE-PTA Study)
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Peripheral Artery Disease
  • Coronary Artery Disease
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Procedure: Systemic Strategy
  • 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
    Intervention: Procedure: Systemic Strategy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 20, 2014)
700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02169258
Other Study ID Numbers  ICMJE B-BR-103-023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ting-Hsing Chao, National Cheng-Kung University Hospital
Study Sponsor  ICMJE National Cheng-Kung University Hospital
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Ting-Hsing Chao, MD National Cheng-Kung University Hospital
PRS Account National Cheng-Kung University Hospital
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP