Myocardial FibrosisNCT03191461
Myocardial Perfusion and Fibrosis in Cancer Survivors
An observational study of Myocardial Fibrosis and Myocardial Injury, run by Virginia Commonwealth University at 2 sites in United States.
Trial summary
This is a cross-sectional pilot study. The investigators seek to obtain early information pertaining to the relationship between measurements of myocardial perfusion reserve and myocardial fibrosis after receipt of Anthracycline-based chemotherapy (≥2 years prior). Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Fibrosis, Myocardial Injury, Chemotherapeutic Toxicity
- What is being tested?
- Adenosine stress test MRI
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Nov 2017to 11 Apr 2024
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators will enroll 10 eligible and consenting men and women aged 21-85 years who either currently have or have had cancer who began their cancer treatment at least 2 years prior to this study and have received anthracycline based chemotherapy. The investigators will enroll an additional group of 6 men and women without cancer or a prior history of a cardiovascular event, matched to 5-year age range with our post-cancer treatment participants
Who may be able to join
- Cancer patients must have Stage I-III breast cancer or lymphoma and have received an anthracycline agent during treatment at least 2 years prior to enrollment in this study.
- Age-matched to cancer survivor with no history of cancer or anthracycline treatment.
- Age 21-85 years of age at the time of enrollment.
- ECOG or Karnofsky performance status of 0-1.
- Life expectancy of greater than 3 months.
- Enrolled control participants must have normal creatinine clearance of >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
Who cannot join
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gadolinium contrast agents or adenosine or history of kidney disease.
- Those with contraindications for MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because the use of gadolinium in cardiac MRI imaging may not be safe in pregnant women. Because some methods of birth control are not 100% reliable, a pregnancy test is required if the participant is a) a sexually active woman of childbearing potential or b) a sexually active peri or post-menopausal women whose last normal menstrual period was less than 12 months ago.
- Coronary revascularization in the past 6 months or known severe multi-vessel CAD previously determined to be not amendable to mechanical intervention.
- Ongoing, unrelieved symptoms thought to represent cardiac ischemia and requiring immediate cardiac catheterization
- History of COPD or asthma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Virginia Commonwealth University
Richmond, Virginia, 23284
Wake Forest Baptist Heath
Winston-Salem, North Carolina, 27157
About this study
This is a cross-sectional pilot study. The investigators seek to obtain early information pertaining to the relationship between measurements of myocardial perfusion reserve and myocardial fibrosis after receipt of Anthracycline-based chemotherapy (≥2 years prior).
Read the detailed description
The primary objective of this cross-sectional pilot study is to determine the myocardial perfusion reserve index (MPRI) in cancer survivors treated with anthracycline chemotherapy relative to similarly aged healthy comparators without a history of cancer treatment. Hypothesis: Cancer survivors treated with anthracycline chemotherapy will have a lower MPRI than similarly aged healthy comparators without a history of cancer treatment.The secondary objective of this cross-sectional pilot study is to determine if MPRI is associated with myocardial fibrosis measured non-invasively with cardiovascular magnetic resonance imaging. Hypothesis: MPRI will be inversely associated with fibrosis burden
Study participants will be consented with pre-study data collection recorded. No randomization will occur as this is a cross-sectional study. Participants in both the cancer survivor and control groups will complete one study visit. No follow-up will be completed.
- Being tested
- Adenosine stress test MRI
- Keywords
- Anthracycline-based chemotherapy, Anth-bC, Chemotherapy, Myocardial Perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenosine stress test MRIDiagnostic test
Also called MRI, Stress Test
Participants will receive a contrasted adenosine stress CMR examination on a 1.5T Siemens Avanto scanner (Siemens Medical Solutions, Malvern, PA) dedicated to cardiovascular imaging. Adenosine stress was selected due to attenuated endothelium dependent and -independent vasodilation after doxorubicin receipt in humans to allow the investigators to understand the potential effect of perivascular fibrosis on perfusion reserve. Standardized CMR protocols will be performed to measure LV volumes (to assess wall motion abnormalities and identify any potential myocardial dysfunction), Native T1, ECV, and myocardial perfusion reserve in the short-axis plane
| Study group | Role | What they receive |
|---|---|---|
| Cancer Patients | Cancer patients with Stage I-III breast cancer or lymphoma that have received an anthracycline agent during treatment at least 2 years prior to enrollment in this study. Adenosine stress test MRI will be performed. Receives: Diagnostic Test: Adenosine stress test MRI | |
| Healthy Controls | Age-matched Healthy Control to cancer survivor with no history of cancer or anthracycline treatment. Adenosine stress test MRI will be performed. Receives: Diagnostic Test: Adenosine stress test MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial perfusion reserve index (MPRI)
The myocardial perfusion reserve index (MPRI) will be measured noninvasively with adenosine stress CMR imaging after dual-bolus first-pass perfusion with gadolinium contrast. The slope of the myocardial signal intensity curve is computed and normalized by the slope of the blood pool signal intensity curve for both rest and stress. MPRI is calculated as the ratio of the stress slope divided by the rest slope.
Measured: During Adenosine Stress Test
Secondary outcomes (2)
Myocardial fibrosis quantification using Myocardial T1
Measured noninvasively with CMR imaging. For myocardial fibrosis quantification with T1 endocardial and epicardial contours are drawn to delineate the myocardium; mean T1 (pre- and post-contrast) is calculated from the pixels within the myocardium. Expected range of T1 is 900-1250ms with higher T1 values considered a worsened outcome.
Measured: During Adenosine Stress Test
Myocardial fibrosis quantification using extracellular volume (ECV)
Measured noninvasively with CMR imaging. The ECV is calculated from the mean myocardial T1 and LV blood T1 pre- and post-contrast. Expected range of ECV is 20-40% with higher ECV values representing a worse outcome.
Measured: During Adenosine Stress Test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start13 Nov 2017
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial FibrosisStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University
- Responsible party
- Sponsor
- Investigators
- Jennifer H Jordan, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191461
- Sponsor's protocol ID
- HM20015409
- Status last verified
- Oct 2024
- First submitted
- 25 May 2017
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Perfusion and Fibrosis in Cancer Survivors
- ClinicalTrials.gov ID
- NCT03191461
- Acronym / sponsor ID
- HM20015409
- Keywords
- Anthracycline-based chemotherapy, Anth-bC, Chemotherapy, Myocardial Perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Wake Forest University
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 19 Jun 2017 (actual)
- 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.
This is a cross-sectional pilot study. The investigators seek to obtain early information pertaining to the relationship between measurements of myocardial perfusion reserve and myocardial fibrosis after receipt of Anthracycline-based chemotherapy (≥2 years prior).
Detailed description
The primary objective of this cross-sectional pilot study is to determine the myocardial perfusion reserve index (MPRI) in cancer survivors treated with anthracycline chemotherapy relative to similarly aged healthy comparators without a history of cancer treatment. Hypothesis: Cancer survivors treated with anthracycline chemotherapy will have a lower MPRI than similarly aged healthy comparators without a history of cancer treatment.The secondary objective of this cross-sectional pilot study is to determine if MPRI is associated with myocardial fibrosis measured non-invasively with cardiovascular magnetic resonance imaging. Hypothesis: MPRI will be inversely associated with fibrosis burden
Study participants will be consented with pre-study data collection recorded. No randomization will occur as this is a cross-sectional study. Participants in both the cancer survivor and control groups will complete one study visit. No follow-up will be completed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer Patients | – | Diagnostic Test: Adenosine stress test MRICancer patients with Stage I-III breast cancer or lymphoma that have received an anthracycline agent during treatment at least 2 years prior to enrollment in this study. Adenosine stress test MRI will be performed. |
| Healthy Controls | – | Diagnostic Test: Adenosine stress test MRIAge-matched Healthy Control to cancer survivor with no history of cancer or anthracycline treatment. Adenosine stress test MRI will be performed. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will enroll 10 eligible and consenting men and women aged 21-85 years who either currently have or have had cancer who began their cancer treatment at least 2 years prior to this study and have received anthracycline based chemotherapy. The investigators will enroll an additional group of 6 men and women without cancer or a prior history of a cardiovascular event, matched to 5-year age range with our post-cancer treatment participants
Key inclusion criteria (7 listed)
- Cancer patients must have Stage I-III breast cancer or lymphoma and have received an anthracycline agent during treatment at least 2 years prior to enrollment in this study.
- Age-matched to cancer survivor with no history of cancer or anthracycline treatment.
- Age 21-85 years of age at the time of enrollment.
- ECOG or Karnofsky performance status of 0-1.
- Life expectancy of greater than 3 months.
Key exclusion criteria (7 listed)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gadolinium contrast agents or adenosine or history of kidney disease.
- Those with contraindications for MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because the use of gadolinium in cardiac MRI imaging may not be safe in pregnant women. Because some methods of birth control are not 100% reliable, a pregnancy test is required if the participant is a) a sexually active woman of childbearing potential or b) a sexually active peri or post-menopausal women whose last normal menstrual period was less than 12 months ago.
- Coronary revascularization in the past 6 months or known severe multi-vessel CAD previously determined to be not amendable to mechanical intervention.
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 |
|---|---|---|
| Adenosine stress test MRIAlso: MRI, Stress TestParticipants will receive a contrasted adenosine stress CMR examination on a 1.5T Siemens Avanto scanner (Siemens Medical Solutions, Malvern, PA) dedicated to cardiovascular imaging. Adenosine stress was selected due to attenuated endothelium dependent and -independent vasodilation after doxorubicin receipt in humans to allow the investigators to understand the potential effect of perivascular fibrosis on perfusion reserve. Standardized CMR protocols will be performed to measure LV volumes (to assess wall motion abnormalities and identify any potential myocardial dysfunction), Native T1, ECV, and myocardial perfusion reserve in the short-axis plane | Diagnostic test | Cancer Patients, Healthy Controls |
Primary outcome
Myocardial perfusion reserve index (MPRI)
Time frame: During Adenosine Stress Test
The myocardial perfusion reserve index (MPRI) will be measured noninvasively with adenosine stress CMR imaging after dual-bolus first-pass perfusion with gadolinium contrast. The slope of the myocardial signal intensity curve is computed and normalized by the slope of the blood pool signal intensity curve for both rest and stress. MPRI is calculated as the ratio of the stress slope divided by the rest slope.
2 secondary outcomes
Myocardial fibrosis quantification using Myocardial T1
Time frame: During Adenosine Stress Test
Myocardial fibrosis quantification using extracellular volume (ECV)
Time frame: During Adenosine Stress Test
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 30 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Jennifer H Jordan, PhD principal investigator
Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Fibrosis and Myocardial Injury, run by Virginia Commonwealth University at 2 sites 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 7 inclusion and 7 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 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Myocardial perfusion reserve index (MPRI) (time frame: During Adenosine Stress Test). 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 30 Oct 2024.