Transient ECG Changes in Patients With Acute Biliary Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Ziv Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Inna Rozenfeld , MD, Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01706068
First received: October 10, 2012
Last updated: October 12, 2012
Last verified: October 2012

October 10, 2012
October 12, 2012
November 2012
November 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01706068 on ClinicalTrials.gov Archive Site
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Transient ECG Changes in Patients With Acute Biliary Disease
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.

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Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample

Patients with ECG changes

  • Acute Cholecystitis
  • Biliary Colic
  • Acute Cholangitis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
May 2014
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients from age 18 and up to 75years old.
  2. Causes of admission to the ED are acute cholecystitis, biliary colic, acute cholangitis
  3. The patient is willing to participate in the study and is able to sign an informed consent form.

Exclusion Criteria:

  1. Elective hospitalization with known and not acute condition.
  2. Inability to give inform consent .
  3. Sepsis as complication of illness.
  4. Chronic ECG changes known by medical history.
  5. Knowing history of IHD.
  6. Previous cardiac catheterization with documented stenosis of at least 1 major coronary artery equal or more 50%.
Both
18 Years to 75 Years
No
Israel
 
NCT01706068
ECGCTIL
Yes
Inna Rozenfeld , MD, Ziv Hospital
Ziv Hospital
Not Provided
Not Provided
Ziv Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP