Clinical Effect of No-touch Harvesting Technique in OPCABG

NCT ID: NCT03729531

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-21
• Study Completion Date: 2021-07-01

Brief Summary

This study aims to investigate the clinical effect of the new saphenous vein harvesting technique "No-touch" in off-pump coronary artery bypass grafting(OPCABG), comparing to the conventional technique. Adopting CTA to evaluate the 3 months patency of the graft, we will compare veins harvested using No-touch technique to saphenous veins using conventional open technique.

Detailed Description

Coronary artery disease(CAD) is a widespread health issue around the world. It is proven that atherosclerosis is a inflammatory disease, and endothelial dysfunction is one of the key factors that initiates the inflammatory response. Accumulating studies indicate that endothelial homeostasis plays a primordial role in the development of atherosclerosis.

Coronary artery bypass grafting(CABG) is the standard treatment of three-vessel or left main coronary artery disease, and its long-term benefits is apparent. Saphenous vein is the most common graft in CABG, however, the long-term patency is only about 50% in one year, as a result, it is urgent to discover a solution to improve the long term potency of vein grafts.

Conventional harvesting technique dissects the perivascular tissue and inject saline to check leakage, which causes damages to the endothelium of the vein, initiating inflammatory response. No-touch technique is a atraumatic, non-distended harvesting technique. According to the criteria, we will randomize the patients into two groups, the conventional and No-touch group, the vein will be used in sequential anastomosis, by comparing the 3 months patency rate assessed by CTA, we aim to compare the clinical outcomes of the two different vein harvesting techniques.

Conditions

Coronary Artery Disease; Graft Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Conventional

The perivascular tissue is stripped off when harvesting the vein, and saline will be used to distend the vein to check for leakage.

Group Type: ACTIVE_COMPARATOR

Conventional vein harvesting technique

Intervention Type: PROCEDURE

Long incision will be used to expose the vein, the perivascular tissue will be dissected carefully by scissors, to check for leakage, the vein will be distended by injecting saline.

No-touch

The vein will be harvested by frequency electrotome and the perivascular tissue will be preserved, the vein will not be distended.

Group Type: EXPERIMENTAL

no-touch vein harvesting technique

Intervention Type: PROCEDURE

The vein will be harvested by low-frequency electrotome, about 5mm surrounding tissue will be preserved with the vein, distention should be avoided, the vein will not be cut off until being anastomosed.

Interventions

Conventional vein harvesting technique

Long incision will be used to expose the vein, the perivascular tissue will be dissected carefully by scissors, to check for leakage, the vein will be distended by injecting saline.

Intervention Type: PROCEDURE

no-touch vein harvesting technique

The vein will be harvested by low-frequency electrotome, about 5mm surrounding tissue will be preserved with the vein, distention should be avoided, the vein will not be cut off until being anastomosed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients from northern China
• first time isolated off-pump coronary artery bypass graft
• echocardiogram show that ejection fraction is over 35%
• the diameter of saphenous vein ≥ 2mm
• the vein graft will be used in sequential anastomosis, and the anastomosis sites ≥2
• be able to sign informed consent form

Exclusion Criteria

• patients who need to undergo urgent surgery
• Severe renal insufficiency(creatinine >200 umol/L)
• allergic to radiocontrast agent
• vein is used to isolated anastomosis
• Combined with malignant tumor or other severe systemic conditions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Municipal Administration of Hospitals

OTHER_GOV

Sponsor Role: collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zheng Ju-bing

Clinical investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ju-bing Zheng, M.D.

Role: STUDY_DIRECTOR

Beijing Anzhen Hospital

Locations

Beijing Anzhen Hospital, Capital medical university

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ju-bing Zheng, M.D.

Role: CONTACT

zhengjubing@hotmail.com

86-13683113119

Kui Zhang, M.D.

Role: CONTACT

86-15001178663

Facility Contacts

Ju-bing Zheng, M.D.

Role: primary

References

Peng Z, Zhao R, Yang Y, Hua K, Yang X. Predictive Value of the CT-Based Visceral Adiposity Tissue Index and Triglyceride-Glucose Index on New-Onset Atrial Fibrillation after Off-Pump Coronary Artery Bypass Graft: Analyses from a Longitudinal Study. Rev Cardiovasc Med. 2023 Nov 30;24(11):338. doi: 10.31083/j.rcm2411338. eCollection 2023 Nov.

Reference Type: DERIVED

PMID: 39076438 (View on PubMed)

Other Identifiers

PX2018027

Identifier Type: -

Identifier Source: org_study_id