Coronary Artery Disease, Peripheral Artery Disease
Conditions
Keywords
coronary artery disease, peripheral artery disease, percutaneous transluminal angioplasty, coronary angiography, revascularization, gene polymorphisms, microRNAs
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
Interventions
PROCEDURESystemic 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.
Sponsors
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
National Cheng-Kung University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to death from any cause | Up to 48 months | total mortality |
| Time to congestive heart failure requiring hospitalization | Up to 48 months | congestive heart failure requiring hospitalization |
| Time to any coronary revascularization | Up to 48 months | planned or unplanned coronary revascularization |
Countries
Taiwan
Contacts
Primary ContactTing-Hsing Chao, MD
Outcome results
None listed