Study to Develop a Non-invasive Marker for Monitoring Myocardial Fibrosis

NCT01230918 | Terminated Phase 2

• 1 other identifier: HI Protocol #2009641-01H
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to determine whether 99Technetium-NC100692 uptake in patients with ACS (MI) can serve as a marker for scar formation as detected by contrast-enhanced MRI during the process of myocardial remodelling after the ischemic insult. Comparison of ACS and HCM Populations: The primary objective is to determine whether TcNC100692 imaging is able to quantify the extent to which myocardial fibrogenesis occurring early post myocardial infarction differs from that in patients with hypertrophic cardiomyopathy. The primary hypothesis is that since fibrogenesis is known to occur most intensely in the first days to weeks post myocardial infarction, while it is a more protracted, less predictable process in HCM, there will be significantly more TcNC100692 uptake in the early post-ACS population than in the HCM population. Control Population: Normal control images will allow for differentiation of uptake in the myocardium.

Conditions

Hypertrophic Cardiomyopathy; Acute Coronary Syndrome

Keywords

Hypertrophic Cardiomyopathy; Acute Coronary Syndrome; Myocardial Fibrosis; Fibrogenesis; Intimal Hyperplasia; Sudden Death; avB3 Integrin Expression

Outcome Measures

Primary Outcomes (1)

• TcNC100692 uptake

  The primary objective is to determine whether TcNC100692 imaging is able to quantify the extent to which myocardial fibrogenesis occurring early post myocardial infarction differs from that in patients with hypertrophic cardiomyopathy.

  3 hours

Study Arms (1)

Diagnostic Imaging

EXPERIMENTAL

A single dose of 800 to 1100 mBq of 99mTc-NC100692 radiopharmaceutical will be injected. Serial cardiac nuclear imaging will be done over a 3 hour period.

Radiation: 99mTc-NC100692

Interventions

99mTc-NC100692 RADIATION

HCM and ACS subjects: 99mTc-NC100692 SPECT scan, CMR and echocardiography images will be obtained and compared. Normal control: 99mTc-NC100692 SPECT scan, CMR and echocardiography imaging obtained for comparison with HCM and ACS images.

Diagnostic Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Acute Coronary Syndrome; Death, Sudden

Interventions

technetium 99m NC 100692

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Myocardial Ischemia; Vascular Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Terrence Ruddy, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: October 29, 2010
• Study Start: May 1, 2011
• Primary Completion: April 20, 2017
• Study Completion: April 20, 2017
• Last Updated: April 24, 2017

Record last verified: 2017-04

Locations

CA (1)