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Evaluation of outcomes of arterial grafts to one versus two or more vessels during heart bypass surgery in diabetic patients

Prospective Randomised Evaluation of Diabetics for graft patency and outcomes following Coronary artery bypass grafting using one versus Two or more arterial grafts - PREDICT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027692
Enrollment
942
Registered
2020-09-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery

Interventions

Intervention1: Two or more arterial grafts: Left ITA and additional one or more arterial grafts- RITA or RA and additional saphenous vein graft/s if require Control Intervention1: Single arterial gra

Sponsors

Indian Council of Medical Research ICMR
Lead Sponsor
Dr Kunal Sarkar
Collaborator
Dr Lokeswara Rao Sajja
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female aged between 18 to 70 yrs 2. Patients with significant triple vessel disease or LMCA stenosis 3. Requiring isolated non emergent CABG 4. Receiving oral anti diabetic agents or insulin (HbA1c less than or equal 10%) 5. Left ventricular ejection fraction more than or equal 35 % 6. Serum creatinine less than or equal 1.5mg/dL 7. Able to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Male or female aged less than 18 and more than 70 years 2. HbA1c more than 10% 3. Serum creatinine more than 1.5% mg/dL 4. Left ventricular ejection fraction less than 35 % 5. Patients undergoing combined procedures 6. Emergent/urgent CABG 7. Patients undergoing redo-CABG 8. Previous cardiac surgery 9. Preoperative severe end-organ dysfunction (on maintenance dialysis, liver failure respiratory failure), cancer or any co-morbidity that reduce life expectancy to less than 5 years. 10. Unsuitable saphenous vein, radial artery and internal thoracic arteries 11. Symptomatic carotid artery stenosis (morethan 70%) 12. COVID-19 positive 13. Not able to provide written informed consent

Design outcomes

Primary

MeasureTime frame
Composite of death from any cause, any stroke, and non fatal myocardial infarction and/or repeat revascularization at 5 yearsTimepoint: 5 years

Secondary

MeasureTime frame
Graft patency and clinical outcomes at one year Timepoint: 1 year

Countries

India

Contacts

Public ContactDr Lokeswara Rao Sajja

Star Hospitals

sajjalr@yahoo.com9849028317

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026