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

Not Applicable

• Conditions: Peripheral Artery Disease; Coronary Artery Disease
• Interventions: Procedure: Systemic Strategy

• Registration Number: NCT02169258
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-19
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-23
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-23
• Last Update Posted: 2015-09-25
• Primary Completion: 2018-06
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Selective Strategy	Systemic 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	Systemic Strategy	Routine coronary angiography before PTA without a previous non-invasive stress test

Primary Outcome Measures

Name	Time	Method
Time to Composite of Major Adverse Cardiac Event (MACE)	up to 48 months	cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization

Secondary Outcome Measures

Name	Time	Method
MACE between the Screening and 30 days after PTA	30 days after indexed PTA	cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization
Time to Composite of major coronary events	Up to 48 months	fatal or nonfatal myocardial infarction, recurrent angina pectoris, and any unplanned coronary revascularization

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan