- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03577821
Early Outcome of Total Arterial Revasclarization in IHD
Surgical Modalities and Early Outcome of Total Arterial Revascularization in CABG
Study Overview
Status
Conditions
Detailed Description
The availability of arterial conduit which is long enough to perform complete arterial revascularization is the limitation of the procedure and it is mandatory to adjust length of the available graft to serve the need. To overcome this problem, sequential or/ and composite grafting techniques are used and one conduit is used for more than one distal anastomoses or multiple arterial grafts are preferred. Bilateral internal mammarian arteries (IMAs), the gastroepiploic artery (GEA), inferior epigastric artery and the radial artery (RA) have been used as conduits in selected patients. However, sequential grafting using arterial grafts may not be convenient for all circumstances and sometimes surgical technique may be challenging. Besides, classical Y-graft technique of RA has the disadvantage of shortening the graft. Harvesting multiple arterial conduits is more time consuming and may result in elevated operative trauma and perioperative complications (sternal dehiscence, sternal infection, pulmonary complications, required laparatomy, prolonged ICU time and hospitalization time, etc.). Every eligible patient should receive total arterial revascularization, the cornerstone of which is BITA grafting. Patients with a body mass index (BMI) of over 35, diabetes or severe airway disease or who are undergoing radio- therapy or immunosuppression are only relatively contra- indicated for BITA use.7 If more conduits are required, the RA can be prepared at the same time as the LITA, and its harvesting is associated with favorable early outcomes Prior to harvesting, a modified Allen test is performed. If a hyperemic response to the previous ischemic hand is noticed within 5 s, the collateral ulnar circulation is adequate. Restoration of the blood circulation to the ischemic hand later than 10 s after the ulnar release excludes the RA from being used.
Duplex examination and pulse oximetry can also be used to preoperatively evaluate the RA and ulnar artery. Moreover, the RA should be avoided when cardiac catheterization has been recently pre- ceded by injuring the vessel and when the RA might be used for future fistulae in patients who are receiving or who are likely to receive dialysis] RAs less than 2 mm in diameter are also avoided due to the possibility of vasospasm.
Finally, the extent of stenosis of the target coronary vessel may also constitute a contraindication for arterial conduit use due to competitive flow. Hence, stenoses of less than 70% in the left coronary bed and less than 90% in a dominant right coronary artery should prevent the use of an arterial graft.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
All patients who will undergo total arterial revascularization either with single or multi vessel coronary artery disease are to be put in the investigator's study work.
-
Exclusion Criteria:
- there is no any.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
target vessel revascularization
Time Frame: baseline-3 months
|
readmission for revascularization due to graft failure
|
baseline-3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major cardiac events
Time Frame: baseline-3 months
|
(myocardial infarction, stroke, readmission for CHF)
|
baseline-3 months
|
Postoperative morbidity
Time Frame: 3 months
|
frequency of peroperative/ postoperative complications according to registration schemes
|
3 months
|
Wound infection
Time Frame: 3 months
|
Readmission for wound infection (superficial sternal wound infection, deep sternal wound infection, saphenous vein related wound infection, need for VAC therapy, need for surgical debridment, need for prolonged antibiotic therapy)
|
3 months
|
Bleeding
Time Frame: Early postoperative up to 1 week
|
surgical bleeding requiring re-exploration
|
Early postoperative up to 1 week
|
Length of ICU stay
Time Frame: Early postoperative up to 1 week
|
number of days in ICU
|
Early postoperative up to 1 week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Doshi R, Rao G, Shlofmitz E, Donnelly J, Meraj P. Comparison of In-Hospital Outcomes After Percutaneous Revascularization for Peripheral Arterial Disease in Patients With a Body Mass Index of >30 kg/m2 Versus </=30 kg/m2 (from the National Inpatient Sample). Am J Cardiol. 2017 Nov 1;120(9):1648-1652. doi: 10.1016/j.amjcard.2017.07.065. Epub 2017 Jul 31.
- Raja SG, Ilsley C, De Robertis F, Lane R, Kabir T, Bahrami T, Simon A, Popov A, Dalby MC, Mason M, Grocott-Mason R, Smith RD, Iqbal MB. Mid-to-long term mortality following surgical versus percutaneous coronary revascularization stratified according to stent subtype: An analysis of 6,682 patients with multivessel disease. PLoS One. 2018 Feb 6;13(2):e0191554. doi: 10.1371/journal.pone.0191554. eCollection 2018.
- Schwann TA, Tatoulis J, Puskas J, Bonnell M, Taggart D, Kurlansky P, Jacobs JP, Thourani VH, O'Brien S, Wallace A, Engoren MC, Tranbaugh RF, Habib RH. Worldwide Trends in Multi-arterial Coronary Artery Bypass Grafting Surgery 2004-2014: A Tale of 2 Continents. Semin Thorac Cardiovasc Surg. 2017 Autumn;29(3):273-280. doi: 10.1053/j.semtcvs.2017.05.018. Epub 2017 Aug 8.
- Buttar SN, Yan TD, Taggart DP, Tian DH. Long-term and short-term outcomes of using bilateral internal mammary artery grafting versus left internal mammary artery grafting: a meta-analysis. Heart. 2017 Sep;103(18):1419-1426. doi: 10.1136/heartjnl-2016-310864. Epub 2017 Jun 23.
- Saraiva J, Antunes PE, Antunes MJ. Coronary artery bypass surgery in young adults: excellent perioperative results and long-term survival. Interact Cardiovasc Thorac Surg. 2017 May 1;24(5):691-695. doi: 10.1093/icvts/ivw407.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- arterial revascularization
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ischemic Heart Disease
-
Genzyme, a Sanofi CompanyTerminatedIschemic Heart Disease | Ischemic Cardiomyopathy | Ischemic Heart FailureBelgium, France, Germany, Italy, Switzerland, United Kingdom
-
University of AlbertaRecruitingCoronary Artery Disease | Stable Ischemic Heart Disease | Beta-blocker TherapyCanada
-
Gerencia de Atención Primaria, MadridServicio Canario de Salud; Avedis Donabedian Research InstituteCompletedIschemic Heart Disease ChronicSpain
-
Michael SekelaCompletedChronic Ischemic Heart DiseaseUnited States
-
Cardiocentro TicinoTerminatedChronic Ischemic Heart DiseaseSwitzerland
-
Rigshospitalet, DenmarkNot yet recruitingChronic Ischemic Heart DiseaseDenmark
-
University of PecsCompleted
-
The University of Texas Health Science Center,...National Heart, Lung, and Blood Institute (NHLBI); Cardiovascular Cell Therapy...CompletedIschemic Cardiomyopathy | Left Ventricular Dysfunction | Angina | Chronic Ischemic Heart DiseaseUnited States
-
Affiliated Hospital to Academy of Military Medical...Ivy Institute of Stem Cells Co. LtdUnknownHeart Failure | Angina | Chronic Ischemic Heart DiseaseChina
-
Florida Cardiovascular Quality NetworkUnknown