Myocardial InfarctionNCT00692991
Using Magnetic Resonance Imaging to Evaluate Heart Vessel Function After Angioplasty or Stent Placement Procedures
An observational study of Myocardial Infarction and Angina, Unstable, run by Johns Hopkins University at 1 site in United States.
Trial summary
Coronary artery disease (CAD) is caused by a narrowing of the blood vessels that supply blood and oxygen to the heart. Balloon angioplasty and stent placement are two treatment options for people with reduced heart function caused by CAD. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Myocardial Infarction, Angina, Unstable, Cardiomyopathy, Hypertrophic
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Jan 2016
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients listed on the cardiac catheterization schedule who are undergoing percutaneous coronary interventions.
Who may be able to join
- Undergoing diagnostic coronary angiography
- Undergoing percutaneous coronary intervention
Who cannot join
- Clinically unstable (i.e., demonstrates unstable cardiac rhythm or hemodynamics, supported on vasopressors or an intra-aortic balloon pump, and/or is actively ischemic) at the time of the MRI procedure
- Unable to undergo MRI procedure (e.g., has non-MRI compatible implanted metallic objects, including cardiac pacemakers or cerebral aneurysm clips that are not MRI compatible)
- Current glomerular filtration rate of less than 60mL/min/1.73m2
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Medical Institution
Baltimore, Maryland, 21287
About this study
Official title: Microvascular Obstruction by Contrast-enhanced MRI Following Percutaneous Coronary Interventions
Coronary artery disease (CAD) is caused by a narrowing of the blood vessels that supply blood and oxygen to the heart. Balloon angioplasty and stent placement are two treatment options for people with reduced heart function caused by CAD. This study will use magnetic resonance imaging (MRI) procedures to evaluate heart function over time in people with CAD who have undergone a balloon angioplasty or stent placement procedure.
Read the detailed description
CAD is the most common type of heart disease in the United States. It occurs when the arteries that supply blood to the heart become hardened and narrowed because of a build-up of cholesterol and plaque on the inner walls of the arteries. Over time, less blood is able to flow through the arteries, depriving the heart of the blood and oxygen it needs. If left untreated, CAD can lead to heart failure, heart attack, and arrhythmias. Someone with plaque build-up may undergo a percutaneous coronary intervention (PCI) to unblock the narrowed arteries and increase blood flow. PCI encompasses a variety of procedures, including balloon angioplasty and stent placement. In balloon angioplasty, a small balloon is inserted into the heart artery and then inflated. This pushes the plaque against the artery walls and widens the artery. Stents are wire mesh tubes that are permanently implanted in the artery to keep it propped open. Although balloon angioplasty and stent placement procedures open up blockages in the large vessels of the heart, the tiny vessels of the heart may become blocked after these procedures, which may affect how the heart heals. This study will use MRI to examine heart function in people who have undergone PCI procedures. Study researchers will attempt to define how often blockages of the tiny vessels occur after PCI procedures, the factors that lead to the blockages, and how often blockages affect healing of the heart.
This study will enroll people who are undergoing a PCI procedure. Participants will undergo an MRI scan of the heart before and after the PCI procedure. During the 72 hours after the procedure, electrocardiogram (EKG) will be used to monitor heart electrical activity. At a study visit 10 days after the PCI procedure and at a follow-up visit 6 to 12 months later, participants will undergo an MRI, EKG, and blood collection. Study staff will call participants every 6 months for 5 years to collect medical information.
- Keywords
- Microvascular Obstruction, Cardiac MRI, Alcohol Ablation, Diagnostic PCI
- Medical subject headings
- Myocardial Infarction, Angina, Unstable, Cardiomyopathy, Hypertrophic
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 |
|---|---|---|
| 1 | People undergoing percutaneous coronary interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of microvascular obstruction by MRI in participants who may or may not have had an acute heart attack; coronary angiographic correlates of MRI microvascular obstruction
Measured: Measured during participant's initial and follow-up MRIs
Secondary outcomes (1)
Relation of presence and extent of microvascular obstruction to clinical outcomes over 5 years
Measured: Measured every 6 months for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startOct 1999
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Katherine C. Wu, Johns Hopkins University
- Investigators
- Kathy Wu, MD, Principal investigator, Johns Hopkins Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692991
- Sponsor's protocol ID
- 566
- Other IDs
- K23HL004444-01
- Status last verified
- Feb 2013
- First submitted
- 4 Jun 2008
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Fernandes VR, Wu KC, Rosen BD, Schmidt A, Lardo AC, Osman N, Halperin HR, Tomaselli G, Berger R, Bluemke DA, Marban E, Lima JA. Enhanced infarct border zone function and altered mechanical activation predict inducibility of monomorphic ventricular tachycardia in patients with ischemic cardiomyopathy. Radiology. 2007 Dec;245(3):712-9. doi: 10.1148/radiol.2452061615. Epub 2007 Oct 2.
PubMed 17911537Rettmann DW, Saranathan M, Wu KC, Azevedo CF, Bluemke DA, Foo TK. High temporal resolution breathheld 3D FIESTA CINE imaging: validation of ventricular function in patients with chronic myocardial infarction. J Magn Reson Imaging. 2007 Jun;25(6):1141-6. doi: 10.1002/jmri.20923.
PubMed 17520725Murthy VL, Wu KC. Advances in cardiac MRI: The multi-ethnic study of atherosclerosis. Curr Cardiol Rep. 2007 Mar;9(1):43-4. No abstract available.
PubMed 17436456Murthy VL, Wu KC. Advances in cardiac MRI: The Dallas Heart Study. Curr Cardiol Rep. 2007 Mar;9(1):43. No abstract available.
PubMed 17436455Schmidt A, Azevedo CF, Cheng A, Gupta SN, Bluemke DA, Foo TK, Gerstenblith G, Weiss RG, Marban E, Tomaselli GF, Lima JA, Wu KC. Infarct tissue heterogeneity by magnetic resonance imaging identifies enhanced cardiac arrhythmia susceptibility in patients with left ventricular dysfunction. Circulation. 2007 Apr 17;115(15):2006-14. doi: 10.1161/CIRCULATIONAHA.106.653568. Epub 2007 Mar 26.
PubMed 17389270Azevedo CF, Amado LC, Kraitchman DL, Gerber BL, Edvardsen T, Osman NF, Rochitte CE, Wu KC, Lima JA. The effect of intra-aortic balloon counterpulsation on left ventricular functional recovery early after acute myocardial infarction: a randomized experimental magnetic resonance imaging study. Eur Heart J. 2005 Jun;26(12):1235-41. doi: 10.1093/eurheartj/ehi137. Epub 2005 Feb 16.
PubMed 15716282Kumbasar B, Wu KC, Kamel IR, Lima JA, Bluemke DA. Left ventricular true aneurysm: diagnosis of myocardial viability shown on MR imaging. AJR Am J Roentgenol. 2002 Aug;179(2):472-4. doi: 10.2214/ajr.179.2.1790472. No abstract available.
PubMed 12130455Heldman AW, Wu KC, Abraham TP, Cameron DE. Myectomy or alcohol septal ablation surgery and percutaneous intervention go another round. J Am Coll Cardiol. 2007 Jan 23;49(3):358-60. doi: 10.1016/j.jacc.2006.10.029. Epub 2007 Jan 4. No abstract available.
PubMed 17239718Luo AK, Wu KC. Imaging microvascular obstruction and its clinical significance following acute myocardial infarction. Heart Fail Rev. 2006 Dec;11(4):305-12. doi: 10.1007/s10741-006-0231-0.
PubMed 17131076Vogel-Claussen J, Rochitte CE, Wu KC, Kamel IR, Foo TK, Lima JA, Bluemke DA. Delayed enhancement MR imaging: utility in myocardial assessment. Radiographics. 2006 May-Jun;26(3):795-810. doi: 10.1148/rg.263055047.
PubMed 16702455Schmidt A, Wu KC. MRI assessment of myocardial viability. Semin Ultrasound CT MR. 2006 Feb;27(1):11-9. doi: 10.1053/j.sult.2005.11.001.
PubMed 16562568Wu KC. Assessment of non-st-segment elevation acute coronary syndromes with cardiac MRI. Curr Cardiol Rep. 2006 Feb;8(1):42-3. No abstract available.
PubMed 16507235Wu KC. Utility of cardiac MRI in the diagnosis of hypertrophic cardiomyopathy. Curr Cardiol Rep. 2006 Feb;8(1):41. No abstract available.
PubMed 16507234Lardo AC, Cordeiro MA, Silva C, Amado LC, George RT, Saliaris AP, Schuleri KH, Fernandes VR, Zviman M, Nazarian S, Halperin HR, Wu KC, Hare JM, Lima JA. Contrast-enhanced multidetector computed tomography viability imaging after myocardial infarction: characterization of myocyte death, microvascular obstruction, and chronic scar. Circulation. 2006 Jan 24;113(3):394-404. doi: 10.1161/CIRCULATIONAHA.105.521450.
PubMed 16432071Foo TK, Ho VB, Saranathan M, Cheng LQ, Sakuma H, Kraitchman DL, Wu KC, Bluemke DA. Feasibility of integrating high-spatial-resolution 3D breath-hold coronary MR angiography with myocardial perfusion and viability examinations. Radiology. 2005 Jun;235(3):1025-30. doi: 10.1148/radiol.2353040090.
PubMed 15914483
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Obstruction by Contrast-enhanced MRI Following Percutaneous Coronary Interventions
- ClinicalTrials.gov ID
- NCT00692991
- Acronym / sponsor ID
- 566
- Keywords
- Microvascular Obstruction, Cardiac MRI, Alcohol Ablation, Diagnostic PCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 1999
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Jun 2008 (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.
Coronary artery disease (CAD) is caused by a narrowing of the blood vessels that supply blood and oxygen to the heart. Balloon angioplasty and stent placement are two treatment options for people with reduced heart function caused by CAD. This study will use magnetic resonance imaging (MRI) procedures to evaluate heart function over time in people with CAD who have undergone a balloon angioplasty or stent placement procedure.
Detailed description
CAD is the most common type of heart disease in the United States. It occurs when the arteries that supply blood to the heart become hardened and narrowed because of a build-up of cholesterol and plaque on the inner walls of the arteries. Over time, less blood is able to flow through the arteries, depriving the heart of the blood and oxygen it needs. If left untreated, CAD can lead to heart failure, heart attack, and arrhythmias. Someone with plaque build-up may undergo a percutaneous coronary intervention (PCI) to unblock the narrowed arteries and increase blood flow. PCI encompasses a variety of procedures, including balloon angioplasty and stent placement. In balloon angioplasty, a small balloon is inserted into the heart artery and then inflated. This pushes the plaque against the artery walls and widens the artery. Stents are wire mesh tubes that are permanently implanted in the artery to keep it propped open. Although balloon angioplasty and stent placement procedures open up blockages in the large vessels of the heart, the tiny vessels of the heart may become blocked after these procedures, which may affect how the heart heals. This study will use MRI to examine heart function in people who have undergone PCI procedures. Study researchers will attempt to define how often blockages of the tiny vessels occur after PCI procedures, the factors that lead to the blockages, and how often blockages affect healing of the heart.
This study will enroll people who are undergoing a PCI procedure. Participants will undergo an MRI scan of the heart before and after the PCI procedure. During the 72 hours after the procedure, electrocardiogram (EKG) will be used to monitor heart electrical activity. At a study visit 10 days after the PCI procedure and at a follow-up visit 6 to 12 months later, participants will undergo an MRI, EKG, and blood collection. Study staff will call participants every 6 months for 5 years to collect medical information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –People undergoing percutaneous coronary interventions. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients listed on the cardiac catheterization schedule who are undergoing percutaneous coronary interventions.
Key inclusion criteria (2 listed)
- Undergoing diagnostic coronary angiography
- Undergoing percutaneous coronary intervention
Key exclusion criteria (4 listed)
- Clinically unstable (i.e., demonstrates unstable cardiac rhythm or hemodynamics, supported on vasopressors or an intra-aortic balloon pump, and/or is actively ischemic) at the time of the MRI procedure
- Unable to undergo MRI procedure (e.g., has non-MRI compatible implanted metallic objects, including cardiac pacemakers or cerebral aneurysm clips that are not MRI compatible)
- Current glomerular filtration rate of less than 60mL/min/1.73m2
- Pregnant
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
Prevalence of microvascular obstruction by MRI in participants who may or may not have had an acute heart attack; coronary angiographic correlates of MRI microvascular obstruction
Time frame: Measured during participant's initial and follow-up MRIs
1 secondary outcome
Relation of presence and extent of microvascular obstruction to clinical outcomes over 5 years
Time frame: Measured every 6 months for 5 years
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 23 Feb 2016.
- Background: PubMed 17911537Fernandes VR, Wu KC, Rosen BD, Schmidt A, Lardo AC, Osman N, Halperin HR, Tomaselli G, Berger R, Bluemke DA, Marban E, Lima JA. Enhanced infarct border zone function and altered mechanical activation predict inducibility of monomorphic ventricular tachycardia in patients with ischemic cardiomyopathy. Radiology. 2007 Dec;245(3):712-9. doi: 10.1148/radiol.2452061615. Epub 2007 Oct 2.
- Background: PubMed 17520725Rettmann DW, Saranathan M, Wu KC, Azevedo CF, Bluemke DA, Foo TK. High temporal resolution breathheld 3D FIESTA CINE imaging: validation of ventricular function in patients with chronic myocardial infarction. J Magn Reson Imaging. 2007 Jun;25(6):1141-6. doi: 10.1002/jmri.20923.
- Background: PubMed 17436456Murthy VL, Wu KC. Advances in cardiac MRI: The multi-ethnic study of atherosclerosis. Curr Cardiol Rep. 2007 Mar;9(1):43-4. No abstract available.
- Background: PubMed 17436455Murthy VL, Wu KC. Advances in cardiac MRI: The Dallas Heart Study. Curr Cardiol Rep. 2007 Mar;9(1):43. No abstract available.
- Background: PubMed 17389270Schmidt A, Azevedo CF, Cheng A, Gupta SN, Bluemke DA, Foo TK, Gerstenblith G, Weiss RG, Marban E, Tomaselli GF, Lima JA, Wu KC. Infarct tissue heterogeneity by magnetic resonance imaging identifies enhanced cardiac arrhythmia susceptibility in patients with left ventricular dysfunction. Circulation. 2007 Apr 17;115(15):2006-14. doi: 10.1161/CIRCULATIONAHA.106.653568. Epub 2007 Mar 26.
- Background: PubMed 15716282Azevedo CF, Amado LC, Kraitchman DL, Gerber BL, Edvardsen T, Osman NF, Rochitte CE, Wu KC, Lima JA. The effect of intra-aortic balloon counterpulsation on left ventricular functional recovery early after acute myocardial infarction: a randomized experimental magnetic resonance imaging study. Eur Heart J. 2005 Jun;26(12):1235-41. doi: 10.1093/eurheartj/ehi137. Epub 2005 Feb 16.
- Background: PubMed 12130455Kumbasar B, Wu KC, Kamel IR, Lima JA, Bluemke DA. Left ventricular true aneurysm: diagnosis of myocardial viability shown on MR imaging. AJR Am J Roentgenol. 2002 Aug;179(2):472-4. doi: 10.2214/ajr.179.2.1790472. No abstract available.
- Results publication: PubMed 17239718Heldman AW, Wu KC, Abraham TP, Cameron DE. Myectomy or alcohol septal ablation surgery and percutaneous intervention go another round. J Am Coll Cardiol. 2007 Jan 23;49(3):358-60. doi: 10.1016/j.jacc.2006.10.029. Epub 2007 Jan 4. No abstract available.
- Results publication: PubMed 17131076Luo AK, Wu KC. Imaging microvascular obstruction and its clinical significance following acute myocardial infarction. Heart Fail Rev. 2006 Dec;11(4):305-12. doi: 10.1007/s10741-006-0231-0.
- Results publication: PubMed 16702455Vogel-Claussen J, Rochitte CE, Wu KC, Kamel IR, Foo TK, Lima JA, Bluemke DA. Delayed enhancement MR imaging: utility in myocardial assessment. Radiographics. 2006 May-Jun;26(3):795-810. doi: 10.1148/rg.263055047.
- Results publication: PubMed 16562568Schmidt A, Wu KC. MRI assessment of myocardial viability. Semin Ultrasound CT MR. 2006 Feb;27(1):11-9. doi: 10.1053/j.sult.2005.11.001.
- Results publication: PubMed 16507235Wu KC. Assessment of non-st-segment elevation acute coronary syndromes with cardiac MRI. Curr Cardiol Rep. 2006 Feb;8(1):42-3. No abstract available.
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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.
Kathy Wu, MD principal investigator
Johns Hopkins Medical Institution
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 Myocardial Infarction and Angina, Unstable, run by Johns Hopkins University 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 2 inclusion and 4 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 23 Feb 2016. 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?
Prevalence of microvascular obstruction by MRI in participants who may or may not have had an acute heart attack; coronary angiographic correlates of MRI microvascular obstruction (time frame: Measured during participant's initial and follow-up MRIs). 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 NCT00692991, which also lists 19 linked publications.
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 23 Feb 2016.