Diabetes MellitusPREDICTNCT00489242
Prediction of CK-MB Release During Otherwise Successful Stenting Procedure
A study testing Procedure / Percutaneous angioplasty in people with Diabetes Mellitus, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Aims of this study will be to assess the difference in CFV/CFR (Coronary flow velocity/reserve) in diabetic vs. non-diabetic patients and to correlate CK-MB, TnI and HsCRP release after otherwise successful coronary stenting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Procedure / Percutaneous angioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Sep 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 years of age
- Stable patients who will undergo PCI (intent to stent)
- Patients with de novo type B2/C lesions of native coronary vessels
Who cannot join
- Patients with acute myocardial infarction (Q wave or non-Q wave with CK-MB 5 times above the upper normal [80 U/L] within 72 hours)
- Patients who are in cardiogenic shock
- Patients with restenotic lesions
- Patients with type A and type B1 lesions of native coronary vessels
- Patients who require use of atherectomy devices for PCI
- Patients who have elevated CK-MB (>16 U/L) or TnI (>2ng/L) at baseline
Show all 11Show fewer
- Patients who receive tirofiban or eptifibatide infusion within 24 hours of PCI
- Patients with known allergy to abciximab and adenosine
- Patients with platelet count <100,000 cell/mm3
- Patients who have co-morbidity which reduces life expectancy to one year
- Patients who are currently participating in another investigational drug/device study
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: PREDICT Trial: Prediction of CK-MB Release During Otherwise Successful Stenting Procedure Correlating With Indicators of Microvascular Obstruction
Aims of this study will be to assess the difference in CFV/CFR (Coronary flow velocity/reserve) in diabetic vs. non-diabetic patients and to correlate CK-MB, TnI and HsCRP release after otherwise successful coronary stenting.
Read the detailed description
Post-procedure CK-MB and troponin I (TnI) and HsCRP elevation, in the absence of obvious procedural events, is most likely caused by distal micro-thromboembolism of platelet aggregates and atheromatous debris causing microvascular bed obstruction. This, in turn, will result in lower coronary flow reserve and regional left ventricular (LV) dysfunction. Therefore, patients with normal CFV/CFR (coronary flow velocity/reserve) by Doppler wire and FFR (fractional flow reserve) by flow wire should have no peri-procedural CK-MB, TnI elevation as compared to patients with peri-procedural CK-MB and TnI elevation where all markers of microcirculation will be reduced. This observation will have a prognostic value at short and long-term. This study may also have clinical implications for patients with intra-coronary stenting and normal microvascular parameters post PCI that these patients may be discharged early while others may need to be monitored in-hospital for an extended period of time.
- Conditions
- Diabetes Mellitus
- Being tested
- Procedure / Percutaneous angioplasty
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure / Percutaneous angioplastyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the difference in CFV/CFR (coronary flow velocity/coronary flow reserve) in diabetic versus non-diabetic patients and to correlate CK-MB, TnI and HsCRP release after otherwise successful coronary stenting.
Secondary outcomes (1)
Correlation of CK-MB, Troponin-I and HsCRP release with CFR<2.0, FFR<0.8 in diabetic vs non-diabetic group. Evaluation of 30-day Major Adverse Cardiac Events (MACE) defined as death, MI, or urgent revascularization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startAug 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Investigators
- Annapoorna S. Kini, MD,, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489242
- Sponsor's protocol ID
- H4S-MC-X022
- Other IDs
- GCO #: 02-1162
- Acronym
- PREDICT
- Status last verified
- Jun 2007
- First submitted
- 19 Jun 2007
- Last updated
- 21 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICT Trial: Prediction of CK-MB Release During Otherwise Successful Stenting Procedure Correlating With Indicators of Microvascular Obstruction
- ClinicalTrials.gov ID
- NCT00489242
- Acronym / sponsor ID
- PREDICT / H4S-MC-X022
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Aug 2003
- Study completion
- Sep 2005 (actual)
- First posted
- 21 Jun 2007 (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.
Aims of this study will be to assess the difference in CFV/CFR (Coronary flow velocity/reserve) in diabetic vs. non-diabetic patients and to correlate CK-MB, TnI and HsCRP release after otherwise successful coronary stenting.
Detailed description
Post-procedure CK-MB and troponin I (TnI) and HsCRP elevation, in the absence of obvious procedural events, is most likely caused by distal micro-thromboembolism of platelet aggregates and atheromatous debris causing microvascular bed obstruction. This, in turn, will result in lower coronary flow reserve and regional left ventricular (LV) dysfunction. Therefore, patients with normal CFV/CFR (coronary flow velocity/reserve) by Doppler wire and FFR (fractional flow reserve) by flow wire should have no peri-procedural CK-MB, TnI elevation as compared to patients with peri-procedural CK-MB and TnI elevation where all markers of microcirculation will be reduced. This observation will have a prognostic value at short and long-term. This study may also have clinical implications for patients with intra-coronary stenting and normal microvascular parameters post PCI that these patients may be discharged early while others may need to be monitored in-hospital for an extended period of time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients >18 years of age
- Stable patients who will undergo PCI (intent to stent)
- Patients with de novo type B2/C lesions of native coronary vessels
Key exclusion criteria (11 listed)
- Patients with acute myocardial infarction (Q wave or non-Q wave with CK-MB 5 times above the upper normal [80 U/L] within 72 hours)
- Patients who are in cardiogenic shock
- Patients with restenotic lesions
- Patients with type A and type B1 lesions of native coronary vessels
- Patients who require use of atherectomy devices for PCI
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 |
|---|---|---|
| Procedure / Percutaneous angioplasty | Procedure or surgery | – |
Primary outcome
To assess the difference in CFV/CFR (coronary flow velocity/coronary flow reserve) in diabetic versus non-diabetic patients and to correlate CK-MB, TnI and HsCRP release after otherwise successful coronary stenting.
1 secondary outcome
Correlation of CK-MB, Troponin-I and HsCRP release with CFR<2.0, FFR<0.8 in diabetic vs non-diabetic group. Evaluation of 30-day Major Adverse Cardiac Events (MACE) defined as death, MI, or urgent revascularization.
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 21 Jun 2007.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Annapoorna S. Kini, MD, principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure / Percutaneous angioplasty in people with Diabetes Mellitus, run by Icahn School of Medicine at Mount Sinai 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 3 inclusion and 11 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 21 Jun 2007. 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 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?
To assess the difference in CFV/CFR (coronary flow velocity/coronary flow reserve) in diabetic versus non-diabetic patients and to correlate CK-MB, TnI and HsCRP release after otherwise successful coronary stenting.. 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 21 Jun 2007.