Coronary Artery Disease Clinical Trial
— GLUTAMICSOfficial title:
Phase III Study of Intravenous Glutamate Infusion for Metabolic Protection of the Heart in Surgery for Unstable Coronary Artery Disease
Verified date | May 2024 |
Source | University Hospital, Linkoeping |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main purpose of this study is to determine whether intravenous glutamate infusion given in association with surgery for unstable coronary artery disease can protect the heart from myocardial injury, postoperative heart failure and death.
Status | Completed |
Enrollment | 865 |
Est. completion date | August 2022 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 85 Years |
Eligibility | Inclusion Criteria: - surgery for unstable coronary artery disease (unstable angina, non-STEMI) - accepted for surgery < 2 weeks after STEMI - coronary surgery for indications above performed with or without cardiopulmonary bypass - coronary surgery for indications above with or without simultaneous valve procedure Exclusion Criteria: - informed consent not possible because of critical condition or other reason - preoperative use of inotropes or mechanical circulatory assist - preoperative dialysis - redo-procedure - unexpected intraoperative finding / event that increased the dignity of the procedure to overshadow the originally planned operation - body weight > 125 kg - food allergy known to have caused flush, rash or asthma |
Country | Name | City | State |
---|---|---|---|
Sweden | Blekingesjukhuset, Karlskrona | Karlskrona | |
Sweden | University Hospital, Linköping | Linköping | |
Sweden | University Hospital, Örebro | Örebro |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Linkoeping | Blekingesjukhuset, Karlskrona, Region Örebro County |
Sweden,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Perioperative Myocardial Infarction, Postoperative Heart Failure or Postoperative Mortality | 30 days | ||
Secondary | Degree of Perioperative Myocardial Injury | p-CK-MB postoperative day 1, p-troponin-T postoperative day 3 | perioperative | |
Secondary | Postoperative Hemodynamic State | Mixed venous oxygen saturation (SvO2) measured at weaning from cardiopulmonary bypass and on arrival to ICU | Until arrival to ICU | |
Secondary | Postoperative Hemodynamic State in Patients With Severely Reduced Left Ventricular Ejection Fraction (LVEF<0.40) | Hemodynamic instability despite inotropes or need for IABP at the end of surgery in patients with severely reduced left ventricular ejection fraction (LVEF<0.40) | End of surgery | |
Secondary | Postoperative Renal Function | maximum p-creatinine value recorded postoperatively < 30 days | 30 days | |
Secondary | Number of Participants With Postoperative Stroke < 24 Hours | Incidence of Postoperative stroke < 24 hours of surgery verifed by CT-scan | 24 hours | |
Secondary | ICU Stay | ICU duration of stay (hours) | ICU stay | |
Secondary | Atrial Fibrillation | Number of patients with atrial fibrillation recorded postoperatively | Hospital stay | |
Secondary | Severe Circulatory Failure in CCS Class IV Patients | Severe circulatory failure according to prespecified criteria as judged by a blinded endpoints committee in CCS class IV patients | 30 days | |
Secondary | 10-year Survival | 10-year survival - related to intervention. Last follow-up August 3, 2022. Follow-up time ranged from 12.7-16.8 years. | 10 year - survival (crude) | |
Secondary | Postoperative Mortality | Postoperative mortality within 30 days of surgery | 30 days |
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