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

NCT02169258 | Unknown

• 1 other identifier: B-BR-103-023
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.The prevalence of significant and complex obstructive coronary artery disease (CAD) is high in patients who have low extremity artery disease (LEAD).
2. 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. 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.

Conditions

Peripheral Artery Disease; Coronary Artery Disease

Keywords

coronary artery disease; peripheral artery disease; percutaneous transluminal angioplasty; coronary angiography; revascularization; gene polymorphisms; microRNAs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• MACE between the Screening and 30 days after PTA

  30 days after indexed PTA

• Time to Composite of major coronary events

  Up to 48 months

Other Outcomes (3)

• Time to death from any cause

  Up to 48 months

• Time to congestive heart failure requiring hospitalization

  Up to 48 months

• Time to any coronary revascularization

  Up to 48 months

Study Arms (3)

Selective Strategy

PLACEBO COMPARATOR

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

Registry

NO INTERVENTION

Clinical decisions are reached by consensus of operators, patients and family as usual care

Systemic Strategy

ACTIVE COMPARATOR

Routine coronary angiography before PTA without a previous non-invasive stress test

Procedure: Systemic Strategy

Interventions

Systemic Strategy PROCEDURE

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.

Also known as: Routine Coronary Angiography before PTA

Selective Strategy; Systemic Strategy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Known LEAD (documented by previous angiography or sonography performed by the operators) admitted for elective PTA

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

Related Publications (4)

• 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.

  PMID: 24357434 BACKGROUND

• 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.

  PMID: 19729114 BACKGROUND

• 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.

  PMID: 20207271 BACKGROUND

• 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.

  PMID: 26927298 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Study Officials

• Ting-Hsing Chao, MD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting-Hsing Chao, MD

CONTACT

886-6-2353535; chaoth@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Attending Physician

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 25, 2015

Record last verified: 2015-09

Locations

TW (1)