Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04864119 |
| Other study ID # |
2021P000435 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 11, 2021 |
| Est. completion date |
March 11, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Massachusetts General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The primary objectives of this study include:
- determine the prevalence of coronary artery disease among patients with type 2
myocardial infarction
- determine the prevalence of hemodynamically significant stenosis among patients with
type 2 myocardial infarction
The investigators hypothesize that patients with type 2 myocardial infarction will have a
high burden of coronary artery plaque and a high prevalence of obstructive coronary artery
disease with hemodynamic significance.
Description:
RECRUITMENT
Patients in the Emergency Department or admitted to Massachusetts General Hospital with an
elevated high-sensitivity cardiac troponin will be identified daily by the Clinical Core
Laboratory at Massachusetts General Hospital. The study investigators will then review the
electronic medical record for each of these patients to determine if the cause of the
patients' elevated high-sensitivity troponin is a type 2 myocardial infarction. If so, their
record will be reviewed to determine if they meet the inclusion criteria for enrollment and
to ensure no exclusion criteria are present. Patients with a type 2 MI who are eligible for
enrollment, will then be approached during their hospital stay to discuss the study and their
interest in consenting and enrolling in our study. Prior to approaching the patient, the
responding clinician treating the patient will be contacted to obtain the primary team's
approval before approaching the patient. In addition to confirming that the patient is an
acceptable candidate for the research, a clinician from the primary team must introduce the
study to the patient and obtain the patient's permission prior to being contacted by our
study staff. 50 patients will be enrolled.
STUDY PROCEDURES
1. Study visits and parameters to be measured (e.g. laboratory tests, x-rays, and other
testing) Patients who enroll in the study will undergo a CT coronary angiogram during
their index admission. In addition, patients will have the option of providing a blood
sample for future research. These biorepository samples may be used in the future for
biomarker analysis to examine associations between serum biomarkers of cardiac injury,
inflammation, and atherosclerosis, and coronary plaque presence/ severity and for
predicting future cardiovascular events up to 1-year. Genetic testing will not be
performed on these samples. There will be no required follow-up visits following their
index admission.
2. Drugs to be used (dose, method, schedule of administration, dose modifications,
toxicities).
Patients will receive nitroglycerin prior to their CT coronary angiogram in the form of
a transdermal patch (0.8 mg/h [2 x 0.4 mg/h]; Nitro-Dur, Merck & Co. Inc., White-House
Station, New Jersey). Nitroglycerin will be administered at least 45 minutes before
electrocardiography-gated coronary CTA.
Iohexol (OMNIPAQUE-350) 350 mg iodine/ml solution 150ml will be used as an iodinated
contrast agent for the scan as per standard protocol at our institution.
3. Devices to be used Patients will undergo a CT coronary angiogram. Once the images are
obtained, they will be sent to HeartFlow Inc for fractional flow analysis using their
FDA-approved CT-FFR software.
4. Procedures/surgical interventions, etc. As this is a prospective observational study, no
procedures or interventions will be made. Any significant findings from the CT scan will
be relayed to the patient and the medical team.
5. Data to be collected and when it will be collected
For patients who enroll in this study, the following information will be collected during
their index admission:
Demographic information Past Medical History Home cardiac medications Cause of type 2
myocardial infarction Laboratory information Cardiac testing Results of CT coronary angiogram
including presence and severity of coronary artery disease, total coronary plaque volume,
calcified plaque volume, non-calcified plaque volume, and LV mass Results of CT-FFR Results
of invasive coronary angiogram (including intravascular ultrasound and optical coherence
tomography) if performed In-hospital outcomes including mortality, acute kidney injury,
recurrent MI, and stroke Discharge cardiac medications
Following discharge:
Using the electronic medical record, the following data will be collected via chart review:
1-year outcomes including all-cause hospital readmission, recurrent MI, heart failure
hospitalization, stroke, and mortality.
Source of subjects and recruitment methods To screen for patients with type 2 MI the
investigators will first identify patients at Massachusetts General Hospital with an elevated
high-sensitivity cardiac troponin on a daily basis through the MGH Central Laboratory. For
patients with elevated troponin, the investigators will review their medical records to
determine if the cause of their troponin elevation is a type 2 MI. For patients with type 2
MI, their medical record will be reviewed to ensure there are eligible for enrollment based
on our inclusion and exclusion criteria.
BIOSTATISCAL ANALYSIS
a. Specific data variables being collected for the study During the index hospitalization
Demographic information Past Medical History Home cardiac medications Cause of type 2
myocardial infarction Laboratory information Cardiac testing Results of CT coronary angiogram
including presence and severity of coronary artery disease, total coronary plaque volume,
calcified plaque volume, non-calcified plaque volume, and LV mass Results of CT-FFR Results
of invasive coronary angiogram (including intravascular ultrasound and optical coherence
tomography) if performed In-hospital outcomes including mortality, acute kidney injury,
recurrent MI, and stroke Discharge cardiac medications
Following discharge:
Using the electronic medical record, the following data will be collected via chart review:
1-year outcomes including all-cause hospital readmission, recurrent MI, heart failure
hospitalization, stroke, and mortality.
DATA & SAFETY MONITORING The principal investigator will review any adverse events that occur
during the CT coronary angiogram. This will involve reviewing the patient's medical record
for any serious or life-threatening allergic reactions, kidney injury from contrast material
necessitating initiation of dialysis, and serious adverse reactions to nitroglycerin. This
review will occur monthly.
Unanticipated problems involving risks to subjects or others including adverse events will be
reported to the study sponsor and the Partners Human Research Committee (IRB) by the
Principal Investigator within 5 working days (7 calendar days) in accordance with Partners
Human Research Committee unanticipated problems including adverse events reporting
guidelines.
Drs. McCarthy and Januzzi will be responsible for monitoring the accuracy and completeness of
case report form entries into REDCap and the informed consent forms.
PRIVACY & CONFIDENTIALITY
Study data will be collected and stored on Partners REDCap (Research Electronic Data
Capture), a secure, electronic SSL-encrypted, web-based application. Only study investigators
will have access to the data.
Blood samples obtained will be stored on-site at Massachusetts General Hospital in a secure
location.
Deidentified data collected by study investigators may be shared with the study Sponsor. This
may include patient demographic data, medical history, cardiac test results, and patient
outcomes. No identifiable data or sensitive information will be shared with the Sponsor. As
this is a single-center study, no data will be shared with other collaborators outside of
Partners. No specimens or data will be stored at collaborating sites outside of partners.
