Coronary Microvascular DysfunctionMADAMENCT01014949
Microcirculation Assessment in Diabetes and Metabolic Syndrome
A study testing Coronary microcirculation assessment in people with Coronary Microvascular Dysfunction and Metabolic Syndrome, run by S.M. Misericordia Hospital at 1 site in Italy.
Trial summary
Abnormal coronary microvascular vasodilation has been demonstrated in patients with diabetes and metabolic syndrome, but the role of insulin resistance in its pathogenesis is not clear. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Microvascular Dysfunction, Metabolic Syndrome, Diabetes
- What is being tested?
- Coronary microcirculation assessment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2008to Jun 2010
- Phase
- Interventional
- 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
- Patients with stable angina or inducible myocardial ischemia
- Coronary arteries without high-grade epicardial stenoses (angiographic stenosis < 50% and fractional flow reserve [FFR] > 0.75)
Who cannot join
- Significant renal insufficiency (serum creatinine > 1.5 mg/dL), a recent (< 1 week) acute coronary syndrome, heart failure, severe valvular disease, or hypertrophic cardiomyopathy.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Interventional Cardiology Unit, Misericordia Hospital
Grosseto, 58100
About this study
Official title: Invasive Coronary Microcirculation Assessment in Diabetes and Metabolic Syndrome
Abnormal coronary microvascular vasodilation has been demonstrated in patients with diabetes and metabolic syndrome, but the role of insulin resistance in its pathogenesis is not clear. The aim of this study is to invasively assess coronary microcirculation and to investigate the relationship of insulin resistance with coronary microvascular dysfunction.
A pressure temperature-sensor-tipped coronary wire will be advanced in coronary arteries without significant lumen reduction. Thermodilution-derived coronary flow reserve (CFR) will be calculated as resting mean transit time (Tmn) divided by hyperemic Tmn (obtained with a 5-min i.v. infusion of adenosine 140 mg/kg/min). An index of microvascular resistance (IMR) will be calculated as the distal coronary pressure at maximal hyperemia divided by the inverse of the hyperemic Tmn. FFR will be calculated by the ratio of Pd/Pa at maximal hyperemia. Insulin resistance (IR) will be assess by the homeostasis model assessment (HOMA) index and plasma IL-6 and TNF-alpha levels will be measured in addition to routine blood examinations before the procedure.
- Being tested
- Coronary microcirculation assessment
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary microcirculation assessmentOther
Patients will arrive to the cardiac catheterization laboratory in a fasting state without discontinuation of their cardiac medications. After conventional diagnostic coronary angiography, 3000-5000 I.U. i.v. heparin will be administered, and a 6F coronary guiding catheter will be placed in the ostium of the coronary artery of interest. A 0.014" coronary pressure wire (Radi Medical Systems, Wilmington, Mass) will be calibrated, equalized to the guiding catheter pressure with the sensor positioned in the coronary ostium, and then advanced to the distal coronary artery (down to at least two thirds of the epicardial vessel length). Coronary flow reserve (CFR), fractional flow reserve (FFR) and the index of microvascular resistance (IMR) will be measured after an intravenous infusion of adenosine [140 ug/kg/min] to induce steady state maximal hyperemia.
| Study group | Role | What they receive |
|---|---|---|
| Control, Diabetes and Metabolic Syndrome | Other | Not described Receives: Other: Coronary microcirculation assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Flow Reserve and Index of Microvascular Resistance values
Measured: Outcome measures will be assessed at the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startJul 2008
- Primary completionNov 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Microvascular DysfunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.M. Misericordia Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014949
- Sponsor's protocol ID
- MDM58100
- Acronym
- MADAME
- Status last verified
- Nov 2009
- First submitted
- 16 Nov 2009
- Last updated
- 22 Jul 2010
- Results posted
- No
Publications
Picchi A, Limbruno U, Focardi M, Cortese B, Micheli A, Boschi L, Severi S, De Caterina R. Increased basal coronary blood flow as a cause of reduced coronary flow reserve in diabetic patients. Am J Physiol Heart Circ Physiol. 2011 Dec;301(6):H2279-84. doi: 10.1152/ajpheart.00615.2011. Epub 2011 Oct 7.
PubMed 21984541
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Coronary Microcirculation Assessment in Diabetes and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01014949
- Acronym / sponsor ID
- MADAME / MDM58100
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- S.M. Misericordia HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 17 Nov 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.
Abnormal coronary microvascular vasodilation has been demonstrated in patients with diabetes and metabolic syndrome, but the role of insulin resistance in its pathogenesis is not clear. The aim of this study is to invasively assess coronary microcirculation and to investigate the relationship of insulin resistance with coronary microvascular dysfunction.
A pressure temperature-sensor-tipped coronary wire will be advanced in coronary arteries without significant lumen reduction. Thermodilution-derived coronary flow reserve (CFR) will be calculated as resting mean transit time (Tmn) divided by hyperemic Tmn (obtained with a 5-min i.v. infusion of adenosine 140 mg/kg/min). An index of microvascular resistance (IMR) will be calculated as the distal coronary pressure at maximal hyperemia divided by the inverse of the hyperemic Tmn. FFR will be calculated by the ratio of Pd/Pa at maximal hyperemia. Insulin resistance (IR) will be assess by the homeostasis model assessment (HOMA) index and plasma IL-6 and TNF-alpha levels will be measured in addition to routine blood examinations before the procedure.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control, Diabetes and Metabolic Syndrome | Other | Other: Coronary microcirculation assessment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with stable angina or inducible myocardial ischemia
- Coronary arteries without high-grade epicardial stenoses (angiographic stenosis < 50% and fractional flow reserve [FFR] > 0.75)
Key exclusion criteria (1 listed)
- Significant renal insufficiency (serum creatinine > 1.5 mg/dL), a recent (< 1 week) acute coronary syndrome, heart failure, severe valvular disease, or hypertrophic cardiomyopathy.
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 |
|---|---|---|
| Coronary microcirculation assessmentPatients will arrive to the cardiac catheterization laboratory in a fasting state without discontinuation of their cardiac medications. After conventional diagnostic coronary angiography, 3000-5000 I.U. i.v. heparin will be administered, and a 6F coronary guiding catheter will be placed in the ostium of the coronary artery of interest. A 0.014" coronary pressure wire (Radi Medical Systems, Wilmington, Mass) will be calibrated, equalized to the guiding catheter pressure with the sensor positioned in the coronary ostium, and then advanced to the distal coronary artery (down to at least two thirds of the epicardial vessel length). Coronary flow reserve (CFR), fractional flow reserve (FFR) and the index of microvascular resistance (IMR) will be measured after an intravenous infusion of adenosine [140 ug/kg/min] to induce steady state maximal hyperemia. | Other | Control, Diabetes and Metabolic Syndrome |
Primary outcome
Coronary Flow Reserve and Index of Microvascular Resistance values
Time frame: Outcome measures will be assessed at the end of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2010.
- Derived from this study: PubMed 21984541Picchi A, Limbruno U, Focardi M, Cortese B, Micheli A, Boschi L, Severi S, De Caterina R. Increased basal coronary blood flow as a cause of reduced coronary flow reserve in diabetic patients. Am J Physiol Heart Circ Physiol. 2011 Dec;301(6):H2279-84. doi: 10.1152/ajpheart.00615.2011. Epub 2011 Oct 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary microcirculation assessment in people with Coronary Microvascular Dysfunction and Metabolic Syndrome, run by S.M. Misericordia Hospital at 1 site in Italy.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jul 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Coronary Flow Reserve and Index of Microvascular Resistance values (time frame: Outcome measures will be assessed at the end of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01014949, which also lists 1 linked publication.
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 22 Jul 2010.