Cardiac Surgical ProceduresPhase 1CYCLO1NCT00990795
Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery
A Phase 1 study testing cyclosporine and saline solution in people with Cardiac Surgical Procedures, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Administration of cyclosporine has been found to have a myocardial protective effect, improving post-operative cardiac function in patients undergoing percutaneous coronary interventions by diminishing infarct size. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgical Procedures
- What is being tested?
- cyclosporine and saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Oct 2010
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, 18 years of age or older
- Patients with multi-vessel coronary artery disease
- Patients undergoing isolated valvular heart surgery (aortic/ mitral)
- Patients undergoing CABG
Who cannot join
- Patients with cardiac arrest
- Patients with ventricular fibrillation
- Patients with cardiogenic shock
- Patients requiring circulatory arrest
- Patients with known hypersensitivity to cyclosporine
- Patients with known renal failure or a GFR <50 ml/min/1.732
Show all 10Show fewer
- Patients with liver failure
- Patients with uncontrolled hypertension
- Women who are pregnant or who are of childbearing age and not on contraception
- Patients with a serum bilirubin level greater than 3 mg/100 mL
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical School Houston
Houston, Texas, 77030
About this study
Official title: A Randomized Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery
Administration of cyclosporine has been found to have a myocardial protective effect, improving post-operative cardiac function in patients undergoing percutaneous coronary interventions by diminishing infarct size. The purpose of the proposed study is to conduct a randomized, controlled clinical trial in patients undergoing isolated valvular heart surgery, or coronary artery bypass surgery. Specifically the investigators will evaluate the cardio-protective effects of cyclosporine on post ischemic-arrest myocardium. The two factors will be treatment group and cyclosporine versus placebo.
Read the detailed description
The specific aim of this study is to perform a randomized controlled study to compare the effects of cyclosporine v. placebo on changes in myocardial functioning associated with open heart surgery for isolated valvular or coronary artery bypass procedures.
The research question is:
Compared to placebo, does administration of cyclosporine just before surgery improve myocardial functioning in terms of:
- Transthoracic ECHO (TTE) assessment of ejection fraction
- Cardiac index (CI), mixed venous oxygen saturation (SVO2), systemic vascular resistance (SVR)
- Length of stay
- 30-d mortality
- Angina Scale
- SF-36 measure of quality of life
- Measures associated with myocardial function:
- Cardiac Index
- Blood glucose level
- Serum Troponin I level
- Free Fatty Acid levels
- Serum CPK-MB levels
- Serum phosphoratase levels
- Conditions
- Cardiac Surgical Procedures
- Being tested
- cyclosporine, saline solution
- Keywords
- open heart surgery, cyclosporine, myocardial protection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporineDrug
Cyclosporine Patients will receive a dose of cyclosporine just after they are heparinized. They will receive 2.5 mg of cyclosporine (Sandimmune, Novartis) per kilogram of body weight. It will be injected into a central venous line at the time the central venous line is inserted by the anesthesia team.
saline solutionDrug
Placebo Group: Patients will undergo the cardiac surgery procedures using standard technique. They will have ischemic arrest of the heart with cold blood cardioplegia using standardized methods of myocardial protection or off-pump CABG. The patients in the placebo group will receive a volumetrically equivalent dose of normal saline to the cyclosporine dose.
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine | Experimental | Cyclosporine Group: Patients will receive a dose of cyclosporine just after they are heparinized. They will receive 2.5 mg of cyclosporine (Sandimmune, Novartis) per kilogram of body weight. It will be injected into a central venous line at the time the central venous line is inserted by the anesthesia team. Receives: Drug: cyclosporine |
| Placebo | Placebo comparator | Placebo: Patients will undergo the cardiac surgery procedures using standard technique. They will have ischemic arrest of the heart with cold blood cardioplegia using standardized methods of myocardial protection or off-pump CABG. The patients in the placebo group will receive a volumetrically equivalent dose of normal saline to the cyclosporine dose. Receives: Drug: saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay (LOS)
Measured: postoperative to 30 days
Secondary outcomes (4)
Left Ventricular Ejection Fraction (TTE)
Measured: postoperative
Cardiac Index
Measured: postoperative
SVO2
Measured: Postoperative
Systemic Vascular Resistance (SVR)
Measured: postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startApr 2010
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: PI left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Jon-Cecil M Walkes, MD, Principal investigator, University of Texas Medical School HoustonHeinrich Taegtmeyer, MD, Study director, University of Texas Medical School HoustonGeorge K Goodrick, PhD, Study chair, University of Texas Medical School Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990795
- Sponsor's protocol ID
- CYCLO1
- Acronym
- CYCLO1
- Status last verified
- Nov 2010
- First submitted
- 5 Oct 2009
- Last updated
- 2 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery
- ClinicalTrials.gov ID
- NCT00990795
- Acronym / sponsor ID
- CYCLO1 / CYCLO1
- Conditions
- Cardiac Surgical Procedures
- Keywords
- open heart surgery, cyclosporine, myocardial protection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution.
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 Oct 2009 (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.
Administration of cyclosporine has been found to have a myocardial protective effect, improving post-operative cardiac function in patients undergoing percutaneous coronary interventions by diminishing infarct size. The purpose of the proposed study is to conduct a randomized, controlled clinical trial in patients undergoing isolated valvular heart surgery, or coronary artery bypass surgery. Specifically the investigators will evaluate the cardio-protective effects of cyclosporine on post ischemic-arrest myocardium. The two factors will be treatment group and cyclosporine versus placebo.
Detailed description
The specific aim of this study is to perform a randomized controlled study to compare the effects of cyclosporine v. placebo on changes in myocardial functioning associated with open heart surgery for isolated valvular or coronary artery bypass procedures.
The research question is:
Compared to placebo, does administration of cyclosporine just before surgery improve myocardial functioning in terms of:
- Transthoracic ECHO (TTE) assessment of ejection fraction
- Cardiac index (CI), mixed venous oxygen saturation (SVO2), systemic vascular resistance (SVR)
- Length of stay
- 30-d mortality
- Angina Scale
- SF-36 measure of quality of life
- Measures associated with myocardial function:
- Cardiac Index
- Blood glucose level
- Serum Troponin I level
- Free Fatty Acid levels
- Serum CPK-MB levels
- Serum phosphoratase levels
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine | Experimental | Drug: cyclosporineCyclosporine Group: Patients will receive a dose of cyclosporine just after they are heparinized. They will receive 2.5 mg of cyclosporine (Sandimmune, Novartis) per kilogram of body weight. It will be injected into a central venous line at the time the central venous line is inserted by the anesthesia team. |
| Placebo | Placebo comparator | Drug: saline solutionPlacebo: Patients will undergo the cardiac surgery procedures using standard technique. They will have ischemic arrest of the heart with cold blood cardioplegia using standardized methods of myocardial protection or off-pump CABG. The patients in the placebo group will receive a volumetrically equivalent dose of normal saline to the cyclosporine dose. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women, 18 years of age or older
- Patients with multi-vessel coronary artery disease
- Patients undergoing isolated valvular heart surgery (aortic/ mitral)
- Patients undergoing CABG
Key exclusion criteria (10 listed)
- Patients with cardiac arrest
- Patients with ventricular fibrillation
- Patients with cardiogenic shock
- Patients requiring circulatory arrest
- Patients with known hypersensitivity to cyclosporine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cyclosporineCyclosporine Patients will receive a dose of cyclosporine just after they are heparinized. They will receive 2.5 mg of cyclosporine (Sandimmune, Novartis) per kilogram of body weight. It will be injected into a central venous line at the time the central venous line is inserted by the anesthesia team. | Drug | Cyclosporine |
| saline solutionPlacebo Group: Patients will undergo the cardiac surgery procedures using standard technique. They will have ischemic arrest of the heart with cold blood cardioplegia using standardized methods of myocardial protection or off-pump CABG. The patients in the placebo group will receive a volumetrically equivalent dose of normal saline to the cyclosporine dose. | Drug | Placebo |
Primary outcome
Length of Stay (LOS)
Time frame: postoperative to 30 days
4 secondary outcomes
Left Ventricular Ejection Fraction (TTE)
Time frame: postoperative
Cardiac Index
Time frame: postoperative
SVO2
Time frame: Postoperative
Systemic Vascular Resistance (SVR)
Time frame: postoperative
Results and safety
The study was stopped early (reason given: PI left institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2010.
Related trials for Cardiac Surgical Procedures
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
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.
Jon-Cecil M Walkes, MD principal investigator
University of Texas Medical School Houston
Heinrich Taegtmeyer, MD study director
University of Texas Medical School Houston
George K Goodrick, PhD study chair
University of Texas Medical School Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cyclosporine and saline solution in people with Cardiac Surgical Procedures, run by The University of Texas Health Science Center, Houston 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 2 Nov 2010. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI left institution.). Results are not available in the source record.
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.
What does the primary outcome measure?
Length of Stay (LOS) (time frame: postoperative to 30 days). 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 2 Nov 2010.