Gastrointestinal BleedingNCT00401908
Factors Contributing To Cardiovascular Morbidity and Mortality in Patients With Gastrointestinal Bleeding
An observational study of Gastrointestinal Bleeding and Acute Coronary Syndrome, run by Maimonides Medical Center at 1 site in United States.
Trial summary
The rate of complication and death of patients with acute digestive tract bleeding is increased in the setting of acute coronary heart disease. The aim of the study is to establish the relative importance of the risk factors contributing to the death rate from acute digestive tract bleeding in patients admitted with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Bleeding, Acute Coronary Syndrome
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: General population.
Who may be able to join
- Consecutive patients with acute CS and acute GI bleeding
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The rate of complication and death of patients with acute digestive tract bleeding is increased in the setting of acute coronary heart disease. The aim of the study is to establish the relative importance of the risk factors contributing to the death rate from acute digestive tract bleeding in patients admitted with acute coronary heart disease.
Read the detailed description
The rate of complication and death of patients with acute digestive tract bleeding is increased in the setting of acute coronary heart disease. The aim of the study is to establish the relative importance of the risk factors contributing to the death rate from acute digestive tract bleeding in patients admitted with acute coronary heart disease. This study will be conducted at MMC and involve collecting your clinical information from our medical records and computer systems. Approximately 200 adult patients with acute coronary heart disease and acute digestive tract bleeding admitted to MMC will be enrolled and followed up for 1 year after recruitment. We propose to develop criteria and a scoring system that will assist your doctors in caring for patients like you in the future.
- Conditions
- Gastrointestinal Bleeding, Acute Coronary Syndrome
- Keywords
- Acute gastrointestinal bleeding, Acute coronary syndrome
- Medical subject headings
- Gastrointestinal Hemorrhage, Acute Coronary Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting-Hui Hsieh, Maimonides Medical Center
- Investigators
- Jianjun Li, MD, Study director, Maimonides Medical CenterScott M Tenner, MD, Principal investigator, Maimonides Medical CenterJacob Shani, MD, Principal investigator, Maimonides Medical CenterTing-Hui Hsieh, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401908
- Sponsor's protocol ID
- 06-09-VA02
- Status last verified
- Sep 2015
- First submitted
- 17 Nov 2006
- Last updated
- 28 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Contributing To Cardiovascular Morbidity and Mortality in Patients With Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT00401908
- Acronym / sponsor ID
- 06-09-VA02
- Conditions
- Gastrointestinal Bleeding, Acute Coronary Syndrome
- Keywords
- Acute gastrointestinal bleeding, Acute coronary syndrome
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 22 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rate of complication and death of patients with acute digestive tract bleeding is increased in the setting of acute coronary heart disease. The aim of the study is to establish the relative importance of the risk factors contributing to the death rate from acute digestive tract bleeding in patients admitted with acute coronary heart disease.
Detailed description
The rate of complication and death of patients with acute digestive tract bleeding is increased in the setting of acute coronary heart disease. The aim of the study is to establish the relative importance of the risk factors contributing to the death rate from acute digestive tract bleeding in patients admitted with acute coronary heart disease. This study will be conducted at MMC and involve collecting your clinical information from our medical records and computer systems. Approximately 200 adult patients with acute coronary heart disease and acute digestive tract bleeding admitted to MMC will be enrolled and followed up for 1 year after recruitment. We propose to develop criteria and a scoring system that will assist your doctors in caring for patients like you in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General population.
Key inclusion criteria (1 listed)
- Consecutive patients with acute CS and acute GI bleeding
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
Related trials for Gastrointestinal Bleeding
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Major Gastrointestinal Bleeding (MGIB)
RecruitingPhase 2
Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
Radiation Induced Proctitis
Recruiting
OTSC vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding
Upper Gastrointestinal Bleeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianjun Li, MD study director
Maimonides Medical Center
Scott M Tenner, MD principal investigator
Maimonides Medical Center
Jacob Shani, MD principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Bleeding and Acute Coronary Syndrome, run by Maimonides Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.