Clinical trial: Study to Develop a Non-invasive Marker for Monitoring Myocardial Fibrosis (NCT01230918)

Eligibility criteria:
HCM Population:

        Inclusion Criteria:

          -  Diagnosis of HCM as defined as: Interventricular septal thickness greater than 12 mm
             on a 2D echocardiogram, or septal: posterior wall thickness as measured on parasternal
             long axis view of >1.3 in the absence of secondary causes of cardiac hypertrophy such
             as aortic stenosis and systemic hypertension.

        Exclusion Criteria:

          -  Concomitant diseases that can lead to myocardial hypertrophy including valvular heart
             disease and uncontrolled hypertension. If HCM is proven by either the presence of a
             family history of HCM or through genotyping, patients with controlled hypertension
             will not be excluded.

          -  Documented coronary artery disease including a history of previous myocardial
             infarction or coronary intervention or revascularization.

          -  Known diabetic cardiomyopathy.

        ACS Population:

        Inclusion Criteria:

          -  Diagnosis of ACS, either NSTEMI as determined by positive myocardial markers or STEMI
             patients who have an onset of symptoms 12 hours or less before presentation and an
             ST-segment elevation of at least 1 mm in two or more contiguous limb leads or of at
             least 2 mm in two or more contiguous precordial leads during prehospital 12-lead ECGs.
             Patients will undergo 99mTc-NC100692 imaging within 1 week of acute myocardial
             infarction.

        Exclusion Criteria:

          -  Patients presenting with an acute STEMI secondary to an occlusive thrombus who were
             revascularized with coronary artery bypass surgery.

          -  Patients with a known prior history of cardiomyopathy of any cause (ex. ischemic,
             hypertrophic, infiltrative, idiopathic dilated), preceding the index referral for
             primary PCI.

          -  Hemodynamic instability or cardiogenic shock.

        Normal Control:

        Inclusion Criteria:

          -  No clinically significant chronic or acute illness as determined by history,
             echocardiogram and/or available reports.

        Exclusion Criteria:

          -  Subjects with pre-existing confounding factors, such as hypertension, diabetes
             mellitus, hyperlipidemia, CAD, known structural heart disease, left ventricular
             dysfunction, previous cerebrovascular event, malignancy, connective tissue or
             inflammatory disease, chronic infection, and hepatic or renal impairment will be
             excluded.

          -  Possess abnormal cardiac structure and function after examination with ECHO

        All populations:

        Inclusion Criteria:

          -  The subject is greater than or equal to 18 years of age at study entry.

          -  Before any study procedure is carried out, the subject is able and willing to comply
             with study procedures and has provided signed and dated informed consent, including
             permission to access medical records.

          -  The subject is male, or a female who is either surgically sterile (has had a
             documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal
             (cessation of menses for more than 1 year), non-lactating, or of childbearing
             potential for whom the result of a urine pregnancy test performed before
             administration of IMP is negative.

        Exclusion Criteria:

          -  Hypersensitivity to any component of 99mTc-NC100692 injection (e.g. p- aminobenzoate).

          -  Pregnancy.

          -  Unwillingness to provide and sign for informed consent.

          -  Creatinine clearance <30 ml/min.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 23-year-old man comes to the emergency department following an episode of syncope.  He was working out when he felt dizzy and passed out without head injury.  He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions.  The patient does not use tobacco, alcohol, or illicit drugs.  His father died suddenly at age 35.  Vital signs are within normal limits.  On physical examination, the patient has a harsh systolic murmur.  The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy.

Patient description (patient's own words): I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average.

Does the patient match the trial criteria? 1