Comparison of Bidirectional Palpation Test and Transit Time Flow Measurement for LIMA-LAD Graft Patency

NCT06934993 | Completed Results

• 1 other identifier: E-83045809-604.01-1014609
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The most important factor determining mortality and morbidity after coronary artery bypass graft (CABG) surgery is graft patency. The LIMA-LAD anastomosis is the most crucial anastomosis because it's revascularizing the most important and large region of the heart, has superior long-term graft patency rates and is considered the gold standard for CABG. Therefore, ensuring the patency of the LIMA-LAD anastomosis is vital for both early and late outcomes. The bidirectional palpation test (BPT), developed in our clinic to assess graft patency, is a subjective test, yet it is simple and reliable. Additionally, transit time flow meter (TTFM) measurements have also been performed. In this study, the efficacy of BPT and the results of TTFM measurements were compared by examining graft patency through early-period coronary CT angiography (CCTA).

Conditions

Coronary Arterial Disease (CAD); Coronary Artery Bypass; LIMA; Graft Patency; LAD (Left Anterior Descending) Coronary Artery Stenosis; Saphenous Vein Graft Patency; LIMA-LAD ANASTOMOSIS; LIMA GREFT PATENCY

Keywords

GRAFT PATENCY; LIMA-LAD ANATOMOSIS; LIMA GRAFT PATENCY; SAPHENOUS VEİN GRAFT PATENCY; CABG

Outcome Measures

Primary Outcomes (2)

• Reliability of Bidirectional Palpation Test (BPT) in Evaluating LIMA-LAD Graft Patency

  The reliability of the Bilateral Palpation Test (BPT) in evaluating LIMA-LAD graft patency was assessed. As detailed in the Study Description section, participants were evaluated intraoperatively as BPT-positive or BPT-negative. Grafts were considered patent in BPT-positive participants and occluded in those with negative findings. In the early postoperative period, contrast-enhanced coronary CT angiography (CCTA), a validated method for assessing graft patency, was performed. The correlation between CCTA and BPT results was then analyzed to evaluate the reliability of the BPT.

  Postoperative first month.

• Reliability of TTFM in Evaluating LIMA-LAD Graft Patency

  Mean Graft Flow (MGF) and Pulsatility Index (PI) were used in this study as TTFM parameters for evaluating graft patency. In the literature, there is no clear consensus on cut-off values for these parameters. Therefore, the values commonly used in the literature were statistically analyzed, and the values that gave the most significant results with our data were accepted as cut-off values. These cut-off values were determined to be 10 ml/min for MGF and 4.5 for PI.

  Postoperative first month

Secondary Outcomes (2)

• Correlation Between Intraoperative TTFM and BPT Results

  postoperative first month.

• The Correlation of SYNTAX 1 and SYNTAX 2 Risk Scores With LIMA-LAD Graft Patency Was Evaluated.

  postoperative first month.

Study Arms (1)

Elective CABG Patients with LIMA-to-LAD Grafts

This cohort consists of patients who underwent elective coronary artery bypass grafting (CABG) with a left internal mammary artery (LIMA) to left anterior descending artery (LAD) anastomosis, and who were evaluated using intraoperative TTFM and BDPT, followed by early postoperative CTA imaging.

Eligibility Criteria

• Age: 41 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

73 patients who underwent coronary artery bypass surgery (CABG) and LIMA-LAD anastomosis

You may qualify if:

• Elective Isolated CABG Surgery: Patients undergoing elective isolated coronary artery bypass grafting (CABG).
• CABG with Additional Cardiac Surgery: Patients who had CABG surgery in conjunction with other cardiac procedures.
• Informed Consent: Patients who provided informed consent to participate in the study.
• Postoperative Follow-Up: Patients who were followed up postoperatively and completed the necessary evaluations.
• CABG patients whose renal functions are suitable for CTA

You may not qualify if:

• Refusal to Participate: Patients who did not wish to participate in the study after being approached.
• Death in Early Postoperative Period: Patients who died in the early postoperative period (3 patients).
• Inability to Perform CABG: Patients for whom CABG could not be performed due to postoperative complications (e.g., elevated creatinine levels leading to inability to perform CABG, 43 patients).
• Patients in whom CT angiography is not appropriate: Such as acute or chronic renal failure

Sponsors & Collaborators

• Abdulgani Orhun YENİGÜN: lead

Study Sites (1)

İstanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine

Istanbul, Bakırköy, 34149, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Leukocyte adhesion deficiency type 1; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Limitations and Caveats

The number of patients participating in the study was limited because the study was single-center and its duration was determined as 1 year.

Results Point of Contact

• Title: Dr. Abdulgani Orhun YENİGÜN
• Organization: Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine

orhunyenigun@gmail.com

+90 05346214600

Study Officials

• Abdulgani Orhun yenigün

  İstanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: August 31, 2023
• Primary Completion: August 27, 2024
• Study Completion: September 14, 2024
• Last Updated: July 8, 2025
• Results First Posted: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning after the publication of results and ending a year later.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent rewiev committee identified for this purpose

Locations

TU (1)