Acute Mesenteric IschemiaFARAMISNCT01788904
Plasma i-FABP as Predictor for Irreversible Bowel Ischemia
An observational study of Acute Mesenteric Ischemia and Bowel Necrosis, run by University Hospital Regensburg at 1 site in Germany.
Trial summary
In the FARAMIS study, we aim to investigate the longitudinal course of intestinal plasma fatty acid binding protein (i-FABP) in patients with acute mesenteric ischemia (AMI) undergoing primary percutaneous angiographic intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Mesenteric Ischemia, Bowel Necrosis
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Jun 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary care clinic
Who may be able to join
- Presence of acute mesenteric ischemia due to stenosis of the superior mesenteric artery, thromboembolization of the superior mesenteric artery, non-occlusive mesenteric ischemia or acute portal vein thrombosis (as confirmed by CT scan)
- The vascular anatomy is suitable for percutaneous revascularization
- A primary endovascular re-vascularisation approach is intended based on an interdisciplinary decision by the visceral surgeon, the vascular surgeon and interventional radiologist. This therapeutic decision is made independently of the proposed FARAMIS study.
- A peripheral or central line is present to perform repeated blood collections
Who cannot join
- Clinically or imaging results indicating that perforation of the bowel is present or suspected
- Hemodynamic instability (shock)
- Pre-existing severe liver or kidney damage (defined as spontaneous international normalized ratio >2 or creatinine >2 mg/dl.)
- Anemia with hemoglobin concentration < 7g/dl
- Pediatric patients
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Regensburg
Regensburg, 93053
Philipp Renner, MD, +49 151 1944 5787, philipp.renner@ukr.de
Peter Heiss, MD, +49 941 944 7401, peter.heiss@ukr.de
About this study
Official title: Plasma i-FABP as Predictor for Irreversible Bowel Ischemia After Interventional Re-vascularization in Patients With Acute Mesenteric Ischemia
In the FARAMIS study, we aim to investigate the longitudinal course of intestinal plasma fatty acid binding protein (i-FABP) in patients with acute mesenteric ischemia (AMI) undergoing primary percutaneous angiographic intervention.
The investigators postulate that patients with fully re-established intestinal blood flow and vital intestines will display a significant drop of plasmatic i-FABP within 24 hours, while patients requiring subsequent intestinal resection due to irreversible bowel necrosis will not.
If true, patients requiring laparotomy and bowel resection could be identified and patients in whom angiographic intervention led to successful cure of disease would not be exposed to potentially perilous surgery.
Read the detailed description
Intestinal plasma fatty acid binding proteins (i-FABP) have been introduced as a powerful marker for the diagnosis of intestinal ischemia. Based on several small studies, this marker is referred to as a sensitive indicator for intestinal ischemia. I-FABP is characterized by its short half-time of eleven minutes in blood circulation, which might allow "real-time" monitoring of necrotic intestinal segments.
Subjects meeting the in-/exclusion criteria will undergo five to six blood collections: one baseline assessment before revascularization, three assessments directly after angiographic intervention (5/30/120 minutes), and one assessment after 24 hours. An additional blood collection will be performed in patients who underwent subsequent surgery. In addition, clinical exams of the patient are carried out.
Subjects will be observed for 72 hours after percutaneous revascularization and retrospectively classified depending on the clinical course: recovering patients or patients undergoing surgery without signs of necrotic segments will be attributed to group A. Patients in whom intestinal necrosis is confirmed by surgery or autopsy will belong to group B. For all patients, clinical and laboratory findings will be reported in a descriptive manner.
To evaluate whether the post-interventional course of plasmatic i-FABP is a reliable predictor for successful revascularization, the minimum level of i-FABP at the time points 5, 30 and 120 Minutes is divided by the baseline (= before intervention) level of i-FABP. This ratio (R) reflects the decrease (or increase) of i-FABP after revascularization. Receiver operating characteristic (ROC)-analysis will be carried out and the area under the curve will be determined for different R-values (e.g. 0.3, 0.5, 0.7).
We postulate that patients with fully re-established intestinal blood flow and vital intestines will display a significant drop of plasmatic i-FAPB within 24 hours, while patients requiring subsequent intestinal resection due to irreversible bowel necrosis will not.
- Conditions
- Acute Mesenteric Ischemia, Bowel Necrosis
- Keywords
- Acute mesenteric ischemia, Percutaneous endovascular revascularization, Intestinal plasma fatty acid binding protein (i-FABP), Bowel necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute mesenteric ischemia | Patients with acute mesenteric ischemia meeting the in-/exclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-interventional course of plasmatic i-FABP as reliable predictor for successful bowel revascularization
Subjects will be observed for 72 hours after percutaneous revascularization. Patients will then be divided into two groups: patients not requiring surgery and not dying from intestinal necrosis will be allocated to group A. Subjects who undergo surgery without signs of necrotic segments will also be attributed to group A. Patients in whom intestinal necrosis is confirmed by surgery or autopsy will belong to group B.
To evaluate whether the post-interventional course of plasmatic i-FABP is a reliable predictor for successful revascularization, the minimum level of i-FABP at the time points 5, 30 and 120 Minutes is divided by the baseline (= before intervention) level of i-FABP. This ratio (R) reflects the decrease (or increase) of i-FABP after revascularization. ROC-analysis will be carried out and the area under the curve will be determined for different R-values.
Measured: 72 hours
Secondary outcomes (1)
Baseline level of i-FABP as predictor of bowel necrosis
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mesenteric IschemiaStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- William Cook Europe
- Responsible party
- Principal investigator, Peter Heiss, University Hospital Regensburg
- Investigators
- Peter Heiss, MD, MS, Principal investigator, University Hospital Regensburg Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788904
- Sponsor's protocol ID
- FARAMIS 2013
- Acronym
- FARAMIS
- Status last verified
- Dec 2013
- First submitted
- 7 Feb 2013
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma i-FABP as Predictor for Irreversible Bowel Ischemia After Interventional Re-vascularization in Patients With Acute Mesenteric Ischemia
- ClinicalTrials.gov ID
- NCT01788904
- Acronym / sponsor ID
- FARAMIS / FARAMIS 2013
- Conditions
- Acute Mesenteric Ischemia, Bowel Necrosis
- Keywords
- Acute mesenteric ischemia, Percutaneous endovascular revascularization, Intestinal plasma fatty acid binding protein (i-FABP), Bowel necrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital RegensburgUniversity, hospital or other
- Collaborators
- William Cook Europe
- Study start
- Feb 2013
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 11 Feb 2013 (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.
In the FARAMIS study, we aim to investigate the longitudinal course of intestinal plasma fatty acid binding protein (i-FABP) in patients with acute mesenteric ischemia (AMI) undergoing primary percutaneous angiographic intervention.
The investigators postulate that patients with fully re-established intestinal blood flow and vital intestines will display a significant drop of plasmatic i-FABP within 24 hours, while patients requiring subsequent intestinal resection due to irreversible bowel necrosis will not.
If true, patients requiring laparotomy and bowel resection could be identified and patients in whom angiographic intervention led to successful cure of disease would not be exposed to potentially perilous surgery.
Detailed description
Intestinal plasma fatty acid binding proteins (i-FABP) have been introduced as a powerful marker for the diagnosis of intestinal ischemia. Based on several small studies, this marker is referred to as a sensitive indicator for intestinal ischemia. I-FABP is characterized by its short half-time of eleven minutes in blood circulation, which might allow "real-time" monitoring of necrotic intestinal segments.
Subjects meeting the in-/exclusion criteria will undergo five to six blood collections: one baseline assessment before revascularization, three assessments directly after angiographic intervention (5/30/120 minutes), and one assessment after 24 hours. An additional blood collection will be performed in patients who underwent subsequent surgery. In addition, clinical exams of the patient are carried out.
Subjects will be observed for 72 hours after percutaneous revascularization and retrospectively classified depending on the clinical course: recovering patients or patients undergoing surgery without signs of necrotic segments will be attributed to group A. Patients in whom intestinal necrosis is confirmed by surgery or autopsy will belong to group B. For all patients, clinical and laboratory findings will be reported in a descriptive manner.
To evaluate whether the post-interventional course of plasmatic i-FABP is a reliable predictor for successful revascularization, the minimum level of i-FABP at the time points 5, 30 and 120 Minutes is divided by the baseline (= before intervention) level of i-FABP. This ratio (R) reflects the decrease (or increase) of i-FABP after revascularization. Receiver operating characteristic (ROC)-analysis will be carried out and the area under the curve will be determined for different R-values (e.g. 0.3, 0.5, 0.7).
We postulate that patients with fully re-established intestinal blood flow and vital intestines will display a significant drop of plasmatic i-FAPB within 24 hours, while patients requiring subsequent intestinal resection due to irreversible bowel necrosis will not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute mesenteric ischemia | – | –Patients with acute mesenteric ischemia meeting the in-/exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary care clinic
Key inclusion criteria (4 listed)
- Presence of acute mesenteric ischemia due to stenosis of the superior mesenteric artery, thromboembolization of the superior mesenteric artery, non-occlusive mesenteric ischemia or acute portal vein thrombosis (as confirmed by CT scan)
- The vascular anatomy is suitable for percutaneous revascularization
- A primary endovascular re-vascularisation approach is intended based on an interdisciplinary decision by the visceral surgeon, the vascular surgeon and interventional radiologist. This therapeutic decision is made independently of the proposed FARAMIS study.
- A peripheral or central line is present to perform repeated blood collections
Key exclusion criteria (5 listed)
- Clinically or imaging results indicating that perforation of the bowel is present or suspected
- Hemodynamic instability (shock)
- Pre-existing severe liver or kidney damage (defined as spontaneous international normalized ratio >2 or creatinine >2 mg/dl.)
- Anemia with hemoglobin concentration < 7g/dl
- Pediatric patients
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
Post-interventional course of plasmatic i-FABP as reliable predictor for successful bowel revascularization
Time frame: 72 hours
Subjects will be observed for 72 hours after percutaneous revascularization. Patients will then be divided into two groups: patients not requiring surgery and not dying from intestinal necrosis will be allocated to group A. Subjects who undergo surgery without signs of necrotic segments will also be attributed to group A. Patients in whom intestinal necrosis is confirmed by surgery or autopsy will belong to group B. To evaluate whether the post-interventional course of plasmatic i-FABP is a reliable predictor for successful revascularization, the minimum level of i-FABP at the time points 5, 30 and 120 Minutes is divided by the baseline (= before intervention) level of i-FABP. This ratio (R) reflects the decrease (or increase) of i-FABP after revascularization. ROC-analysis will be carried out and the area under the curve will be determined for different R-values.
1 secondary outcome
Baseline level of i-FABP as predictor of bowel necrosis
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
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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.
Peter Heiss, MD, MS principal investigator
University Hospital Regensburg Germany
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 Acute Mesenteric Ischemia and Bowel Necrosis, run by University Hospital Regensburg at 1 site in Germany.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Dec 2013. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter G Heiss, MD, MS (+49 941 944 7401, peter.heiss@ukr.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-interventional course of plasmatic i-FABP as reliable predictor for successful bowel revascularization (time frame: 72 hours). It is what the study was designed to measure, not a finding.
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 12 Dec 2013.