Health TrialsbyHealthPanel

Heart Attack Research Program: Platelet Sub-Study (HARP)

ConditionMyocardial Infarction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age21-99
SponsorNYU Langone Health

About this trial

This prospective observational cohort study, will investigate the platelet phenotype, platelet genetic composition, and role of platelets as effector cells in women and men with myocardial infarction (MINOCA or MI-CAD) and controls. This study, which will take place at NYU and Bellevue Medical Center, and participating external sites. May have concurrent enrollment with the HARP Main Imaging (NCT02914483). Additionally, a sex, group of age and race matched disease controls 'CATH-NOCA' composed of women and men with stable angina referred for cardiac catheterization, will be enrolled. Blood obtained during the initial catheterization and 2 months post-MI will be utilized for platelet testing.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Acute ischemic symptoms compatible with diagnosis of MI, such as chest pain or anginal equivalent symptoms at rest or new onset exertional anginal equivalent symptoms

Elevation of troponin to above the laboratory upper limit of normal (ULN)

ST segment elevation of ≥1mm on 2 contiguous ECG leads

Willing to provide informed consent and comply with all aspects of the protocol

Disqualifiers

Recent use of vasospastic agents, such as cocaine, triptans, or ergot alkaloids (≤1 month)

Alternate explanation for troponin elevation, such as hypertensive urgency, acute exacerbation of heart failure, chronic elevation due to kidney disease, pulmonary embolism, cardiac trauma

Pregnancy

Thrombolytic therapy for STEMI (qualifying event)

Trial population

This study may have concurrent enrollment with the HARP Main Imaging (NCT02905357). This study population includes women and men who present to the hospital with an MI, with non-obstructive coronary artery disease or obstructive artery disease, are eligible for blood collection. Additionally, a sex, group of age and race matched disease controls 'CATH-NOCA' will be composed of women and men with stable angina referred for cardiac catheterization.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

350 Participants
are grouped into 3 trial groups
Group A: MINOCA
Group B: MI-CAD
Group C: CATH-NOCA

Trial outcomes

Primary outcomes

1

Examination of Platelet Activity Markers

Time frame
1 year
2

Examination of Markers of Cardiovascular Disease Risk

This will include additional examination of known thrombosis, Inflammation, metabolic disease, and lipids/lipoprotein markers.

Time frame
1 year
3

Cellular and molecular mechanism of myocardial infarction in women

To further investigate this mechanism, recent advances in microRNA, RNA, DNA expression profiling, and plasma and serum collections will be used.

Time frame
1 year

Secondary outcomes

1

Examination of non-coding and coding mRNA profiles in women with MI and matched controls

Specific transcripts associated with platelet activation, plaque destabilization, and different cardiovascular diseases will be analyzed at the genetic level.

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov
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