- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01706068
Transient ECG Changes in Patients With Acute Biliary Disease
Background:
The importance of ischemic ECG changes including St segment elevation, ST segment depression or T wave inversion that indicate myocardial ischemia are well established and require appropriate investigation and treatment.
However, there is an abundance of clinical situation, with apparently ischemic ECG change not indicate traditionally coronary artery related ischemia and therefore require prompt recognition and treatment of underlying condition, that may be serious and life-threatened. For example of such conditions are pericarditis, myocarditis, aortic dissection, electrolyte abnormalities, intracranial hemorrhage and hypothermia.
Together with them, an ECG ST segment changes may appeared in abdominal serious illness such as pancreatitis and cholecystitis(17,18,19,20,23). Whereas in pancreatitis various vasoactive and toxic for myocardium substances released, the cause of ST segment changes in cholecystitis are discussed and includes tachycardia , vagal reflexes, changed in plasma rennin activity resulted by distension of the gallbladder.
The certain proportion of the patients with ECG changes actually didn't have coronary artery disease(9,15) or other acute cardiac condition and therefore require treatment of the underlie illness only without spend the time for cardiac investigation or special treatment(1,3,4,7,8). Some kind of treatment may be even harmful for the patients with abdominal illness such as thrombolytic, anticoagulant, aggressive antiaggregant therapy or unnecessary cardiac catheterization.
In the medical literature the investigators found some case reports and works about the ECG changes in acute biliary disease in patient with knowing cardiac disease and without it, but actually incidence of ECG changes that suggest but not represent an acute coronary illness isn't knowing.
Therefore this is necessary to investigate actually incidence of ECG changes that mimic acute coronary syndrome in acute cholecystitis and acute biliary disease and determined clinical and laboratory characteristics that helps to differentiate this patients.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Zefat, Israel, 13100
- Ziv Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients from age 18 and up to 75years old.
- Causes of admission to the ED are acute cholecystitis, biliary colic, acute cholangitis
- The patient is willing to participate in the study and is able to sign an informed consent form.
Exclusion Criteria:
- Elective hospitalization with known and not acute condition.
- Inability to give inform consent .
- Sepsis as complication of illness.
- Chronic ECG changes known by medical history.
- Knowing history of IHD.
- Previous cardiac catheterization with documented stenosis of at least 1 major coronary artery equal or more 50%.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ECGCTIL
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 Acute Cholecystitis
-
Konya Meram State HospitalCompleted
-
Azienda Ospedaliero, Universitaria PisanaCompletedAcute CholecystitisItaly
-
University Hospital, GhentCompletedUncomplicated Acute CholecystitisBelgium, Qatar
-
The University of Texas Health Science Center at...CompletedAcute Cholecystitis | Chronic CholecystitisUnited States
-
IRCCS Policlinico S. MatteoCompleted
-
Istituto Clinico Humanitas Mater DominiRecruiting
-
Hvidovre University HospitalZealand University Hospital; Hillerod Hospital, DenmarkWithdrawn
-
Hospital Italiano de Buenos AiresCompletedAcute CholecystitisArgentina
-
Sisli Hamidiye Etfal Training and Research HospitalCompletedAcute Cholecystitis
-
Mansoura UniversityUnknownAcute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective StudyAcute CholecystitisEgypt